Label: STAY AGELESS DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25- octinoxate and zinc oxide lotion
- NDC Code(s): 83182-2650-2
- Packager: THE SKIN CLINIC L L C
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 26, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
Apply to all skin exposed to the sun.
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- For children under 6 months of age: Ask a doctor.
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 time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENTS
Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-20, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Cocos Nucifera Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Quercus Suber Bark Extract, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak Root Extract, Centella Asiatica Extract, Polygonum Aviculare Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Vitis Vinifera Fruit Cell Extract, Sodium Benzoate, Lepidium Sativum Sprout Extract.
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STAY AGELESS DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 25
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83182-2650 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOCETYL STEARATE (UNII: 3RJ7186O9W) SORBITOL (UNII: 506T60A25R) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) PEG-100 STEARATE (UNII: YD01N1999R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) OCTISALATE (UNII: 4X49Y0596W) XANTHAN GUM (UNII: TTV12P4NEE) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LINGONBERRY (UNII: 0UNK9RZQ7X) QUERCUS SUBER BARK (UNII: 8R5219271Q) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLUCONOLACTONE (UNII: WQ29KQ9POT) ISOMALT (UNII: S870P55O2W) CALCIUM GLUCONATE (UNII: SQE6VB453K) SODIUM BENZOATE (UNII: OJ245FE5EU) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83182-2650-2 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2023 Labeler - THE SKIN CLINIC L L C (091520496) Establishment Name Address ID/FEI Business Operations COSMETIC SOLUTIONS, LLC 807907928 manufacture(83182-2650)