Label: AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 68828-409-01, 68828-409-02, 68828-409-03 - Packager: Jafra cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply at least every 2 hours.
Sun 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 your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses •
Children under 6 months of age: ask a doctor.
-
INACTIVE INGREDIENT
Inactive ingredients
Alumina, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 3, Cerium Oxide, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hydrogenated Lecithin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyltaurate Copolymer, Lecithin, Maltodextrin, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Phenoxyethanol, Phytosterols, Polyester-8, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Royal Jelly, Sodium Benzoate, Sodium Hyaluronate, Sodium PCA, Squalane, Styrene/Acrylates Copolymer, Sucrose Stearate, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Tocopheryl Acetate, Tuber Magnatum Extract, VP/Eicosene Copolymer, Water/Aqua, Xanthan Gum - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-409 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SOYBEAN (UNII: L7HT8F1ZOD) PEG-100 STEARATE (UNII: YD01N1999R) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) AVOCADO OIL (UNII: 6VNO72PFC1) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) SQUALANE (UNII: GW89575KF9) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) COCOA (UNII: D9108TZ9KG) CERIC OXIDE (UNII: 619G5K328Y) POLYSORBATE 60 (UNII: CAL22UVI4M) ROYAL JELLY (UNII: L497I37F0C) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CERAMIDE NP (UNII: 4370DF050B) ALUMINUM OXIDE (UNII: LMI26O6933) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYALURONATE SODIUM (UNII: YSE9PPT4TH) OLIVE OIL (UNII: 6UYK2W1W1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-409-01 7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2019 2 NDC:68828-409-02 14 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2019 3 NDC:68828-409-03 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/09/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/09/2019 Labeler - Jafra cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-409)
