Label: SUNSCREEN SPORT SPF 50 EXCHANGE SELECT- avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 55301-778-06 - Packager: Your Military Exchange
- 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 June 4, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply liberally 15 minutes
before sun exposure and as needed. • 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, especially 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPORT SPF 50 EXCHANGE SELECT
avobenzone 3.0% homosalate 10.0% octocrylene 6.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-778 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 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 10 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 6 g in 100 mL Inactive Ingredients Ingredient Name Strength Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Benzyl Alcohol (UNII: LKG8494WBH) Butyloctyl Salicylate (UNII: 2EH13UN8D3) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Methylparaben (UNII: A2I8C7HI9T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Propylparaben (UNII: Z8IX2SC1OH) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55301-778-06 237 mL in 1 CONTAINER; Type 0: Not a Combination Product 12/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2017 Labeler - Your Military Exchange (001695568) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(55301-778) , label(55301-778)