-
ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%.................................................................Sunscreen
Octisalate 5%......................................................................Sunscreen
Octocrylene 10%.................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions • Apply liberally 15 minutes before sun exposure
and as needed. • Children under 6 months of age: ask a doctor.
• 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. • For sunscreen use: • apply to all skin exposed to the
sun. • reapply as needed or after towel drying, swimming, or sweating - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 50 WEGMAN
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-113 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 15 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 mL Inactive Ingredients Ingredient Name Strength Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Ethylhexylglycerin (UNII: 147D247K3P) Phenoxyethanol (UNII: HIE492ZZ3T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-113-05 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013 Labeler - Wegman (059650069) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(47124-113) , label(47124-113)