NDC 62191-801 Oi Lin Natural Emulsion Spf 30

Sunscreen, Titanium Dioxide

NDC Product Code 62191-801

NDC 62191-801-06

Package Description: 1 JAR in 1 BOX > 71 g in 1 JAR

NDC Product Information

Oi Lin Natural Emulsion Spf 30 with NDC 62191-801 is a a human over the counter drug product labeled by Sunrider Manufacturing L.p.. The generic name of Oi Lin Natural Emulsion Spf 30 is sunscreen, titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Oi Lin Natural Emulsion 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.

  • ALANINE (UNII: OF5P57N2ZX)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BIOTIN (UNII: 6SO6U10H04)
  • .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • CHRYSANTHEMUM INDICUM TOP (UNII: 607YAE70V1)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DENDRANTHEMA INDICUM FLOWER (UNII: I6OER6U04L)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GAMMA ORYZANOL (UNII: SST9XCL51M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCINE (UNII: TE7660XO1C)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
  • IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
  • LEMON (UNII: 24RS0A988O)
  • MAGNESIUM ASPARTATE (UNII: R17X820ROL)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • ORANGE PEEL WAX (UNII: 0U715N387C)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PINUS PINASTER WHOLE (UNII: J27867F361)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ROYAL JELLY (UNII: L497I37F0C)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
  • EDETATE TRISODIUM (UNII: 420IP921MB)
  • UREA (UNII: 8W8T17847W)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CORN OIL (UNII: 8470G57WFM)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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: Sunrider Manufacturing L.p.
Labeler Code: 62191
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: 10-02-2017 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: 12-31-2021 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.

Oi Lin Natural Emulsion Spf 30 Product Label Images

Oi Lin Natural Emulsion 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

Otc - Purpose

USES:  HELPS PREVENT SUNBURN

Indications & Usage

  • Directions:Apply liberally 15 minutes before sun exposure.reapply:after 40 minutes of swimming or swating Immediately after towel dryingat least every 2 hours.Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin againg. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:limit time in the sun, expecially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor

Otc - Active Ingredient

ACTIVE INGREDIENT:  TITANIUM DIOXIDE 6.5%

Inactive Ingredient

OTHER INGREDIENTS:  Water (Deionized)Caprylic/Capric TriglycerideGlycerinJojoba EstersHelianthus Annuus (Sunflower) Seed OilPrunus Amygdalus Dulcis (Sweet Almond) OilVP/Eicosene CopolymerSorbitan PalmitateCyclopentasiloxaneCitrus Aurantium Dulcis (Orange) Peel WaxPolysorbate 60Octyldodecyl NeopentanoateSorbitan StearateCetyl AlcoholGlyceryl StearatePEG-100 StearateDimethiconolRetinyl PalmitateTocopheryl AcetateOryzanolBisabololStearyl GlycyrrhetinateJasminum Officinale Flower ExtractPersea Gratissima (Avocado) OilTocopherolZinc OxideSaccharide HydrolysateMagnesium AspartateBiotinGlycineAlanineUreaZea Mays (Corn) OilHypericum Perforatum Flower/Leaf/Stem ExtractXanthan GumRoyal Jelly ExtractCitrus Medica Limonum ExtractHamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig ExtractCamellia Sinensis Leaf ExtractAloe Barbadensis Leaf Juice (Aloe Vera Gel)BeeswaxChrysanthemum Indicum Flower ExtractImperata Cylindrica Root ExtractPinus Pinaster Bark ExtractVitis Vinifera (Grape) Seed OilAesculus Hippocastanum (Horse Chestnut) Seed ExtractPhenoxyethanolTrisodium EDTAPotassium SorbateEthylhexylglycerinCitric AcidTriethoxycaprylylsilane

Warnings

WARNING: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

* Please review the disclaimer below.