Label: KIDS SUNSCREEN SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 47124-112-05 - Packager: Wegman
- 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 May 2, 2018
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WARNINGS AND PRECAUTIONS
Active ingredients Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%.................................................................Sunscreen
Octisalate 5%......................................................................Sunscreen
Octocrylene 10%.................................................................Sunscreen - 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
KIDS SUNSCREEN SPF 50
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-112 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 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 Homosalate (UNII: V06SV4M95S) 15 g in 100 mL Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) 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) TROLAMINE (UNII: 9O3K93S3TK) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-112-05 177 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(47124-112) , label(47124-112)