Label: OLAY TOTAL EFFECTS CC TONE CORRECTING BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- avobenzone, octisalate, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 37000-355-50 - Packager: The Procter & Gamble Manufacturing Company
- 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 July 12, 2018
If you are a consumer or patient please visit this version.
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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*, titanium dioxide, isopropyl lauroyl sarcosinate, acetyl glucosamine, panthenol**, tocopheryl acetate***, dimethicone, caprylyl glycol, dimethiconol, C13-14 isoparaffin, cetearyl glucoside, cetearyl alcohol, laureth-7, stearyl alcohol, behenyl alcohol, cetyl alcohol, carbomer, polyacrylamide, aminomethyl propanol, citric acid, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, sodium benzoate, iron oxides.
*Vitamin B3, **Vitamin B5, ***Vitamin E
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OLAY TOTAL EFFECTS CC TONE CORRECTING BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM
avobenzone, octisalate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-355 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) NIACINAMIDE (UNII: 25X51I8RD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) N-ACETYLGLUCOSAMINE (UNII: V956696549) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DOCOSANOL (UNII: 9G1OE216XY) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-7 (UNII: Z95S6G8201) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PEG-100 STEARATE (UNII: YD01N1999R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J) POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG) SODIUM BENZOATE (UNII: OJ245FE5EU) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37000-355-50 1 in 1 CARTON 11/07/2013 1 50 mL 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 not final part352 11/07/2013 Labeler - The Procter & Gamble Manufacturing Company (004238200)