HYDRATING SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% spray 
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 moderate protection against sunburn

Warnings
Flammable: Do not use near heat, flame, or while smoking.
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water
to remove.
Stop use and ask a doctor if • rash or irritation develops and last

Avoid spraying in eyes. Contents under pressure. Do not puncture
or incinerate. Do not store at temperature above 120°F.

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. • Hold container 4 to 6 inches
from the skin to apply. • Do not spray directly into face. Spray on
hands then apply to face. • Do not apply in windy conditions.
• Use in a well-ventilated area. • For sunscreen use: • apply to all
skin exposed to the sun. • Reapply as needed or after towel
drying, swimming, or sweating.

Inactive Ingredients:
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Aloe Barbadensis Leaf Extract
Caprylic/Capric Triglyceride
Diethylhexyl Syringylidenemalonate
Fragrance
Glycerin
Retinyl Palmitate
Stearoxytrimethylsilane
Tocopherol

image description

HYDRATING SPF 50 
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
Glycerin (UNII: PDC6A3C0OX)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
Stearoxytrimethylsilane (UNII: 9862TW94B2)  
Tocopherol (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1120-05156 g in 1 CAN; Type 0: Not a Combination Product11/16/2016
2NDC:0363-1120-06283 g in 1 CAN; 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 Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-1120) , label(0363-1120)

Revised: 4/2018
Document Id: fe9b1f48-0f54-4d5e-b1b8-e114546530f3
Set id: 91af959c-7c70-4a99-81fa-c3be3f8ff58d
Version: 2
Effective Time: 20180427
 
Walgreens