Hydrating SPF 50: Package Insert and Label Information

HYDRATING SPF 50- 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 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
(click image for full-size original)

HYDRATING SPF 50 avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1121
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 15 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
ALOE VERA LEAF
Aluminum Starch Octenylsuccinate
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
Dimethicone
EDETATE DISODIUM
Ethylhexylglycerin
Glycerin
Phenoxyethanol
Polyglyceryl-3 Distearate
VITAMIN A PALMITATE
Sorbitan Isostearate
Sorbitol
Stearic Acid
Tocopherol
TROLAMINE
EICOSYL POVIDONE
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-1121-06 236 mL in 1 CAN None
2 NDC:0363-1121-07 296 mL in 1 TUBE None
3 NDC:0363-1121-03 89 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 (0363-1121), label (0363-1121)

Revised: 05/2018 Walgreens

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.