Label: EXCHANGE SELECT SUNSCREEN SPF 70- avobenzone homosalate octisalate octocrylene oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 55301-013-56 - Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
- 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 October 24, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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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
- Other information
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Inactive ingredients
Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.
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INGREDIENTS AND APPEARANCE
EXCHANGE SELECT SUNSCREEN SPF 70
avobenzone homosalate octisalate octocrylene oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-013 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 10 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) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-100 STEARATE (UNII: YD01N1999R) BENZYL ALCOHOL (UNII: LKG8494WBH) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) PALMITIC ACID (UNII: 2V16EO95H1) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MYRISTYL ALCOHOL (UNII: V42034O9PU) TRICAPRYLIN (UNII: 6P92858988) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CETYL ALCOHOL (UNII: 936JST6JCN) LAURYL ALCOHOL (UNII: 178A96NLP2) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-013-56 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/24/2013 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)