NDC 69423-388 Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free

Avobenzone, Homosalate, Octisalate, And Octocrylene

NDC Product Code 69423-388

NDC Code: 69423-388

Proprietary Name: Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, And Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 69423 - The Procter & Gamble Manufacturing Company
    • 69423-388 - Olay Total Effects Moisturizer With Sunscreen

NDC 69423-388-10

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 100 mL in 1 BOTTLE, PUMP

NDC 69423-388-15

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 15 mL in 1 BOTTLE, PLASTIC

NDC 69423-388-50

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 50 mL in 1 BOTTLE, PUMP

NDC Product Information

Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free with NDC 69423-388 is a a human over the counter drug product labeled by The Procter & Gamble Manufacturing Company. The generic name of Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free is avobenzone, homosalate, octisalate, and octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: The Procter & Gamble Manufacturing Company

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 4 g/100mL
  • OCTISALATE 4.5 g/100mL
  • OCTOCRYLENE 2.6 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • RETINYL PROPIONATE (UNII: 32JK994WMC)
  • DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Procter & Gamble Manufacturing Company
Labeler Code: 69423
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free Product Label Images

Olay Total Effects Moisturizer With Sunscreen Broad Spectrum Spf 15 Fragrance-free Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distr. by PROCTER & GAMBLE,


CINCINNATI, OH 45202

Otc - Purpose

Active ingredientsPurposeAvobenzone 3.0%SunscreenHomosalate 4.0%SunscreenOctisalate 4.5%SunscreenOctocrylene 2.6%Sunscreen

Uses

  • Helps prevent sunburnif used as directed with other sun protection measures (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do Not Use

  • On damaged or broken skin

When Using This Product

  • Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

  • Rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposurereapply at least every 2 hoursuse water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months: ask a doctor

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, glycerin, niacinamide*, dimethicone, isopropyl isostearate, panthenol**, tocopheryl acetate***, sodium ascorbyl phosphate^, retinyl propionate^^, camellia sinensis leaf extract^*, BHT^**, tapioca starch, dimethiconol, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, carbomer, sodium hydroxide, PEG-100 stearate, titanium dioxide, polymethylsilsesquioxane, benzyl alcohol, methylparaben, ethylparaben, propylparaben, iodopropynyl butylcarbamate*Vitamin B3, **Pro-Vitamin B5, ***Vitamin E, ^Vitamin C,^^Vitamin A, ^*Green Tea Antioxidant, ^**Antioxidant

* Please review the disclaimer below.

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