NDC | 69423-195-12, 69423-195-17 |
Set ID | 59187729-c166-58fe-e053-2991aa0abe47 |
Category | HUMAN OTC DRUG LABEL |
Packager | The Procter & Gamble Manufacturing Company |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 4.0% Sunscreen Octisalate 4.5% Sunscreen Octocrylene 2.6% Sunscreen 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, polyethylene, dimethicone, isopropyl isostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, propylene glycol, niacinamide*, panthenol**, tocopheryl acetate, stearyl alcohol, caprylyl glycol, behenyl alcohol, 1,2-hexanediol, phenoxyethanol, cetyl alcohol, dimethiconol, PEG-100 stearate, fragrance, sodium benzoate, cetearyl glucoside, cetearyl alcohol, disodium EDTA, stearic acid, palmitic acid, ascorbic acid.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OLAY COMPLETE UV 365 DAILY MOISTURIZER NORMAL BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-195 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 HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) PEG-100 STEARATE (UNII: YD01N1999R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) DIMETHICONE (UNII: 92RU3N3Y1O) NIACINAMIDE (UNII: 25X51I8RD4) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ASCORBIC ACID (UNII: PQ6CK8PD0R) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DOCOSANOL (UNII: 9G1OE216XY) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PHENOXYETHANOL (UNII: HIE492ZZ3T) PALMITIC ACID (UNII: 2V16EO95H1) EDETATE DISODIUM (UNII: 7FLD91C86K) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-195-12 1 in 1 CARTON 09/11/2017 1 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69423-195-17 1 in 1 CARTON 09/11/2017 2 177 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 not final part352 09/11/2017 Labeler - The Procter & Gamble Manufacturing Company (004238200)