Label: SUNSCREEN- octinoxate, octisalate, zinc oxide cream
- NDC Code(s): 55910-726-10
- Packager: OLD EAST MAIN CO.
- 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 March 10, 2022
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- claims
- active ingredients
- Purpose
- uses
- Warnings
- Do not use
- When using this product
- stop use and ask a doctor
- Keep out of reach of children
-
directions
Directions
■ apply liberally 15 minutes before sun exposure
■ reapply:
■ after 80 minutes of swimming or sweating
■ immediately after towel drying■ at least every 2 hours
■ 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 the sun, especially from
10 a.m. – 2 p.m.
■ wear long-sleeved shirts, pants, hats
and sunglasses
■ children under 6 months of age: Ask a doctor - Other information
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inactive ingredients
water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA
- claims
- disclaimer
- Adversation reaction
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SUNSCREEN
octinoxate, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-726 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 562 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 250 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1000 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1000 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPANEDIOL (UNII: 5965N8W85T) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-100 STEARATE (UNII: YD01N1999R) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) (UNII: VP5LS3541F) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) triethoxycaprylylsilane (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-726-10 28.3 g in 1 PACKAGE; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/01/2019 Labeler - OLD EAST MAIN CO. (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-726) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-726)
