HYDRATING SPF 50- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion 
Walgreens

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.

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Drug Facts

Active ingredients                                                                         Purpose
Avobenzone 3%............................................................................Sunscreen
Homosalate 15%..........................................................................Sunscreen
Octisalate 5%...............................................................................Sunscreen
Octocrylene 10%..........................................................................Sunscreen

Uses • helps prevent sunburn • higher SPF gives more sunburn
protection • retains SPF after 80 minutes of activity in the water or
sweating • provides high protection against sunburn

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away

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 information • protect the product in this container from
excessive heat and direct sun • may stain fabrics

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.

image description

HYDRATING SPF 50 
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1121-06236 mL in 1 CAN; Type 0: Not a Combination Product11/16/2016
2NDC:0363-1121-07296 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
3NDC:0363-1121-0389 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/16/2016
Labeler - Walgreens (008965063)
Registrant - Product Quiest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quiest Mfg927768135manufacture(0363-1121) , label(0363-1121)

Revised: 5/2018
Document Id: 1245e1ee-91e1-43a2-b777-55db63ce4207
Set id: e67d9c22-9d3a-4724-b5ec-12617bf37f1a
Version: 2
Effective Time: 20180501
 
Walgreens