Label: HYDRATING SPF 50- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-1121-03, 0363-1121-06, 0363-1121-07 - Packager: Walgreens
- 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 1, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%............................................................................Sunscreen
Homosalate 15%..........................................................................Sunscreen
Octisalate 5%...............................................................................Sunscreen
Octocrylene 10%..........................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
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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
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INACTIVE INGREDIENT
Inactive ingredients Aloe Barbadensis Leaf Extract, Aluminum
Starch Octenylsuccinate, Carbomer, Dimethicone, Disodium EDTA,
Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Polyglyceryl-3
Distearate, Retinyl Palmitate, Sorbitan Isostearate, Sorbitol, Stearic Acid,
Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING SPF 50
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1121 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 ALOE VERA LEAF (UNII: ZY81Z83H0X) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) Phenoxyethanol (UNII: HIE492ZZ3T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 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:0363-1121-06 236 mL in 1 CAN; Type 0: Not a Combination Product 11/16/2016 2 NDC:0363-1121-07 296 mL in 1 TUBE; Type 0: Not a Combination Product 11/16/2016 3 NDC:0363-1121-03 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/16/2016 Labeler - Walgreens (008965063) Registrant - Product Quiest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quiest Mfg 927768135 manufacture(0363-1121) , label(0363-1121)