Label: DAILY MOISTURIZER- octinoxate, octisalate lotion
- NDC Code(s): 72288-338-26
- Packager: Amazon.com Services LLC
- 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 May 20, 2022
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- Official Label (Printer Friendly)
- active information
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- stop use and ask a doctor if
- Keep out of reach of children
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Directions
- apply liberally 15 minures before sun exposure
- reapply at least every 2 hours:
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF Value of 15 or higher and other sun protection measures including:
- limit the time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants hats and sunglasses
- children umder 6 months of age: ask a doctor
- Other information
-
Inactive ingredients
water, C12-15 alkyl benzoate, cetearyl alcohol, glycerin, dimethicone, Glycine soja (soybean) seed extract, bis-phenylpropyl dimethicone, arachidyl alcohol, cetearyl glucoside, benzyl alcohol, panthenol, ethylene/acrylic acid copolymer, behenyl alcohol, steareth-2, fragrance, steareth-21, polymethyl methacrylate, polyacrylamide, arachidyl glucoside, disodium EDTA, C13-14 isoparaffin, laureth-7, silica, chlorphenesin, BHT, titanium dioxide, mica
- Adverse Reactions Section
- principal display panel
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INGREDIENTS AND APPEARANCE
DAILY MOISTURIZER
octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-338 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) SOYBEAN (UNII: L7HT8F1ZOD) BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) BENZYL ALCOHOL (UNII: LKG8494WBH) PANTHENOL (UNII: WV9CM0O67Z) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) DOCOSANOL (UNII: 9G1OE216XY) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-338-26 1 in 1 CARTON 04/26/2018 1 188 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 part352 04/26/2018 Labeler - Amazon.com Services LLC (128990418) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(72288-338) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72288-338)
