Label: EXCHANGE SELECT BABY SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
- NDC Code(s): 55301-006-56
- Packager: ARMY AND AIR FORCE EXCHANGE SERVICE
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Avobenzone 3.0 %
- helps prevent sunburn
- If used as directed with other sun protection measures( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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. May stain some fabrics.
- apply liberally 15 minutes before sun exposure
- 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
- protect this product from excessive heat and direct sun
- Inactive ingredients
Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.
- Principal Display Panel
8 FL. OZ. (236 mL)
- Questions or comments?
- INGREDIENTS AND APPEARANCE
EXCHANGE SELECT BABY SUNSCREEN SPF 50
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-006 Route of Administration TOPICAL DEA Schedule 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 13 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-006-56 226 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 10/07/2013 Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)