Label: MEIJER- avobenzone, homosalate, octisalate, octocrylene lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 41250-035-22 - Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 July 12, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
-
Warnings
For external use only
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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 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 sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor.
-
Inactive ingredients
Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, Silica, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Methicone, Sodium Polyacrylate, Benzyl Alcohol, Beeswax, Ethylhexyl Stearate, Dimethicone, Cetyl Dimethicone, Xanthan Gum, Trimethylsiloxysilicate, Trideceth-6, Disodium EDTA, Dipotassium Glycyrrhizate, BHT, Chlorphenesin, Fragrance..
- Principal Display Panel
- Other information
-
INGREDIENTS AND APPEARANCE
MEIJER
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-035 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BENZYL ALCOHOL (UNII: LKG8494WBH) YELLOW WAX (UNII: 2ZA36H0S2V) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) TRIDECETH-6 (UNII: 3T5PCR2H0C) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-035-22 85 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/12/2013 Labeler - Meijer Distribution Inc (006959555)