Label: OLAY TOTAL EFFECTS MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 15 FRAGRANCE-FREE- avobenzone, homosalate, octisalate, and octocrylene lotion
- NDC Code(s): 69423-388-10, 69423-388-15, 69423-388-50
- Packager: The Procter & Gamble Manufacturing Company
- 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 April 4, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
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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 sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
- Other information
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Inactive ingredients
Water, glycerin, niacinamide*, dimethicone, isopropyl isostearate, panthenol**, tocopheryl acetate***, sodium ascorbyl phosphate^, retinyl propionate^^, camellia sinensis leaf extract^*, BHT^**, tapioca starch, dimethiconol, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, carbomer, sodium hydroxide, PEG-100 stearate, titanium dioxide, polymethylsilsesquioxane, benzyl alcohol, methylparaben, ethylparaben, propylparaben, iodopropynyl butylcarbamate
*Vitamin B3, **Pro-Vitamin B5, ***Vitamin E, ^Vitamin C,
^^Vitamin A, ^*Green Tea Antioxidant, ^**Antioxidant
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OLAY TOTAL EFFECTS MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 15 FRAGRANCE-FREE
avobenzone, homosalate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-388 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 4 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.6 g in 100 mL Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) RETINYL PROPIONATE (UNII: 32JK994WMC) DIMETHICONOL GUM (UNII: 4MJ9GU3T1P) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PALMITIC ACID (UNII: 2V16EO95H1) BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DOCOSANOL (UNII: 9G1OE216XY) CETYL ALCOHOL (UNII: 936JST6JCN) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM (UNII: 7FLD91C86K) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) GREEN TEA LEAF (UNII: W2ZU1RY8B0) STARCH, TAPIOCA (UNII: 24SC3U704I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-388-50 1 in 1 CARTON 07/10/2019 1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:69423-388-10 1 in 1 CARTON 07/10/2019 2 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:69423-388-15 1 in 1 CARTON 07/10/2019 04/01/2023 3 15 mL in 1 BOTTLE, PLASTIC; 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 07/10/2019 Labeler - The Procter & Gamble Manufacturing Company (004238200)
