Label: SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 46994-714-34
- Packager: Moran Foods, 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 September 11, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
-
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, especiallyu 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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- principal display panel
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-714 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.3 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 101 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 101 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) SORBITOL (UNII: 506T60A25R) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) BENZYL ALCOHOL (UNII: LKG8494WBH) TOCOPHEROL (UNII: R0ZB2556P8) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CHLORPHENESIN (UNII: I670DAL4SZ) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) OLETH-3 (UNII: BQZ26235UC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46994-714-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/28/2016 Labeler - Moran Foods, LLC (095484572) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(46994-714)
