Label: SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 11822-1914-2
- Packager: Rite Aid
- 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 October 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
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Directions
- apply liberaly 15 minutes before sun exposure
- apply to all skin exposed to the sun
- 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especialy 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, silica, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, glyceryl stearate, PEG-100 stearate, caprylyl methicone, cetyl dimethicone, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, behenyl alcohol, xanthan gum, glycerin, pentylene glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, chlorphenesin, disodium EDTA, fragrance, diethylhexyl 2,6-naphthalate, BHT, trideceth-6
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SPL UNCLASSIFIED SECTION
May stain or damage some fabrics or surfaces.
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
www.riteaid.com
SATISFACTION GUARANTEE:
If you're not satisifed,
We'll happily refund your money.
This product is not manufacturedor distributed by Johnson & Johnson Consumer Inc., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30.
- principal display panel
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INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1914 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 Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) BENZYL ALCOHOL (UNII: LKG8494WBH) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETYL DIMETHICONE 150 (UNII: 5L694Y0T22) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) DOCOSANOL (UNII: 9G1OE216XY) xanthan gum (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) ALLYL METHACRYLATE (UNII: G2IG50653Z) ethylhexyl stearate (UNII: EG3PA2K3K5) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) diethylhexyl 2,6-naphthalate (UNII: I0DQJ7YGXM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIDECETH-6 (UNII: 3T5PCR2H0C) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1914-2 88 mL in 1 TUBE; Type 0: Not a Combination Product 09/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/08/2019 Labeler - Rite Aid (014578892) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11822-1914) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(11822-1914)
