Label: OLAY SENSITIVE CALMING FACIAL MOISTURIZER BROAD SPECTRUM SPF 15 FRAGRANCE FREE- octinoxate and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69423-429-75 - 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 December 6, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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, isohexadecane, niacinamide*, aloe barbadensis leaf juice, cucumis sativus (cucumber) fruit extract, camellia sinensis leaf extract, tocopheryl acetate, hydroxyacetophenone, C13-14 isoparaffin, steareth-21, laureth-7, steareth-2, stearyl alcohol, behenyl alcohol, cetyl alcohol, disodium EDTA, polyacrylamide, oleth-3 phosphate, triethoxycaprylylsilane, phenoxyethanol.
*Vitamin B3
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 mL Carton
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INGREDIENTS AND APPEARANCE
OLAY SENSITIVE CALMING FACIAL MOISTURIZER BROAD SPECTRUM SPF 15 FRAGRANCE FREE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-429 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) CUCUMBER (UNII: YY7C30VXJT) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ISOHEXADECANE (UNII: 918X1OUF1E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) STEARETH-21 (UNII: 53J3F32P58) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DOCOSANOL (UNII: 9G1OE216XY) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETYL ALCOHOL (UNII: 936JST6JCN) STEARETH-2 (UNII: V56DFE46J5) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-7 (UNII: Z95S6G8201) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-429-75 2 in 1 PACKAGE 08/27/2019 1 75 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 08/27/2019 Labeler - The Procter & Gamble Manufacturing Company (004238200) Establishment Name Address ID/FEI Business Operations The Procter & Gamble Manufacturing Company 017745779 manufacture(69423-429) , pack(69423-429)
