NDC 62551-213 Photo-age Sunscreen Spf 30

Octinoxate, Titanium Dioxide, Octisalate, Octocrylene, Oxybenzone

NDC Product Code 62551-213

NDC CODE: 62551-213

Proprietary Name: Photo-age Sunscreen Spf 30 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: Octinoxate, Titanium Dioxide, Octisalate, Octocrylene, Oxybenzone 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

  • 62551 - Advanced Aesthetics

NDC 62551-213-52

Package Description: 1 TUBE in 1 BOX > 56 mL in 1 TUBE (62551-213-12)

NDC Product Information

Photo-age Sunscreen Spf 30 with NDC 62551-213 is a a human over the counter drug product labeled by Advanced Aesthetics. The generic name of Photo-age Sunscreen Spf 30 is octinoxate, titanium dioxide, octisalate, octocrylene, oxybenzone. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Photo-age Sunscreen Spf 30 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SQUALANE (UNII: GW89575KF9)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PAPAYA (UNII: KU94FIY6JB)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)

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: Advanced Aesthetics
Labeler Code: 62551
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-12-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Photo-age Sunscreen Spf 30 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

Active Ingredients

OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE)  7.5%TITANIUM DIOXIDE 6%OCTISALATE (ETHYLHEXYL SALICYLATE)  5%OCTOCRYLENE  1.5%OXYBENZONE (BENZOPHENONE-3)  1%

Purpose

SUNSCREEN

Uses

HELPS PREVENT SUNBURN. HIGHER SPF PROVIDES MORE SUNBURN PROTECTION.

Warnings

FOR EXTERNAL USE ONLY.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 SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

APPLY SUNSCREEN TO ALL EXPOSED AREAS 30 MINUTES BEFORE GOING OUTDOORS. MASSAGE THOROUGHLY INTO SKIN AND ALLOW TO ABSORB. REAPPLY EVERY TWO HOURS TO ENSURE MAXIMUM PROTECTION - MORE FREQUENTLY WHEN SWIMMING OR ACTIVE.

Inactive Ingredients

AQUA (WATER), CYCLOPENTASILOXANE, GLYCERIN, CETYL ALCOHOL, C12-15 ALKYL BENZOATE, POTASSIUM CETYL PHOSPHATE, STEARIC ACID, DIMETHICONE, CETYL DIMETHICONE, CAPRYLYL METHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, VP/EICOSENE COPOLYMER, ALUMINA, ALUMINUM STARCH OCTENYLSUCCINATE, HYDROGENATED VEGETABLE OIL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PEG-40 HYDROGENATED CASTOR OIL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BORON NITRIDE, CAPRYLYL GLYCOL, LECITHIN, PHENOXYETHANOL, SQUALANE, CARBOMER, POLYHYDROXYSTEARIC ACID, CHLORPHENESIN, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CARRAGEENAN, HEXYLENE GLYCOL, SODIUM HYDROXIDE, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, VITIS VINIFERA (GRAPE) SEED EXTRACT, SODIUM HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT, RETINYL PALMITATE, ASCORBYL PALMITATE.

* Please review the disclaimer below.