Hydrating SPF 30: Package Insert and Label Information

HYDRATING SPF 30- avobenzone, homosalate, octisalate and octocrylene 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.

Active ingredients Purpose
Avobenzone 3%……………………………………………………………Sunscreen
Homosalate 10%…………………………………………………………..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

Warnings
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 lasts.

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

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Aloe Barbadensis Leaf Extract, Benzyl Alcohol,
Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl
Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate,
Fragrance, Glycerin, Oleth-3, Polyamide-8, Retinyl Palmitate, Sodium
Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

Questions? 1-800-925-4733

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HYDRATING SPF 30
avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1124
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (AVOBENZONE) Avobenzone 3 g in 100 mL
Homosalate (HOMOSALATE) Homosalate 10 g in 100 mL
Octisalate (OCTISALATE) Octisalate 5 g in 100 mL
Octocrylene (OCTOCRYLENE) Octocrylene 10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ALOE VERA LEAF
Benzyl Alcohol
MEDIUM-CHAIN TRIGLYCERIDES
Chlorphenesin
Diethylhexyl Syringylidenemalonate
EDETATE DISODIUM
Ethylhexyl Palmitate
Glycerin
Oleth-3
POLYAMIDE-8 (4500 MW)
VITAMIN A PALMITATE
Sodium Ascorbyl Phosphate
Sorbitol
Tocopherol
TROLAMINE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1124-06 236 mL in 1 TUBE None
2 NDC:0363-1124-03 89 mL in 1 TUBE None
3 NDC:0363-1124-07 296 mL in 1 TUBE None
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 Operations
Product Quiest Mfg 927768135 manufacture (0363-1124), label (0363-1124)

Revised: 04/2018 Walgreens

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