Label: MARY KAY TIMEWISE DAYTIME DEFENDER SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone/octisalate/octocrylene lotion
- NDC Code(s): 51531-7385-1
- Packager: Mary Kay Inc.
- 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 September 28, 2023
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- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
Adults and children over 6 months of age: ■ apply liberally15 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from10 a.m.–2 p.m. • wear long-sleeve shirts, pants, hatsand sunglasses ■ children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
water/eau/aqua, propanediol, glycerin, silica, caprylyl methicone, ceteareth-25, aluminum starch octenylsuccinate, ammonium acryloyldimethyltaurate/VP copolymer, beeswax/ cire d'abeille/cera alba, glyceryl stearate, niacinamide, dimethicone, phenoxyethanol, disodium ethylene dicocamide PEG-15 disulfate, VP/eicosene copolymer, hydroxyacetophenone, opuntia ficus-indica fruit extract, xanthan gum, disodium EDTA, ethylhexylglycerin, saccharomyces cerevisiae extract, sucrose stearate, alcohol, dipropylene glycol, ethyl macadamiate, resveratrol, sodium benzoate, tocopheryl acetate, oligopeptide-1.
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INGREDIENTS AND APPEARANCE
MARY KAY TIMEWISE DAYTIME DEFENDER SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone/octisalate/octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-7385 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) PRICKLY PEAR FRUIT (UNII: 18V8PAQ629) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) RESVERATROL (UNII: Q369O8926L) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETEARETH-25 (UNII: 8FA93U5T67) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SUCROSE STEARATE (UNII: 274KW0O50M) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ETHYL MACADAMIATE (UNII: ANA2NCS6V1) OLIGOPEPTIDE-10 (UNII: Q46328TRNK) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) YELLOW WAX (UNII: 2ZA36H0S2V) PROPANEDIOL (UNII: 5965N8W85T) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-7385-1 1 in 1 CARTON 07/20/2023 1 29.783 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/20/2023 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-7385)
