Label: OLAY REGENERIST MINERAL SUNSCREEN HYDRATING MOISTURIZER BROAD SPECTRUM SPF 15- zinc oxide lotion
- NDC Code(s): 69423-489-50
- 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 June 12, 2023
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- 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, caprylic/capric triglyceride, isohexadecane, glycerin, steareth-21, polyacrylamide, stearyl alcohol, polyhydroxystearic acid, C13-14 isoparaffin, behenyl alcohol, triethoxycaprylylsilane, hydroxyacetophenone, phenoxyethanol, cetyl alcohol, laureth-7, steareth-2, disodium EDTA, niacinamide, tocopheryl acetate, palmitoyl pentapeptide-4
- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 50 mL carton
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INGREDIENTS AND APPEARANCE
OLAY REGENERIST MINERAL SUNSCREEN HYDRATING MOISTURIZER BROAD SPECTRUM SPF 15
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-489 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 9.7 g in 100 mL Inactive Ingredients Ingredient Name Strength ISOHEXADECANE (UNII: 918X1OUF1E) LAURETH-7 (UNII: Z95S6G8201) NIACINAMIDE (UNII: 25X51I8RD4) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) TOCOPHEROL (UNII: R0ZB2556P8) DOCOSANOL (UNII: 9G1OE216XY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) STEARETH-2 (UNII: V56DFE46J5) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG) STEARETH-21 (UNII: 53J3F32P58) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-489-50 1 in 1 CARTON 11/25/2021 08/01/2024 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 final M020 11/25/2021 08/01/2024 Labeler - The Procter & Gamble Manufacturing Company (004238200)
