HYDRATING SPF 30- avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% lotion

Hydrating SPF 30 by

Drug Labeling and Warnings

Hydrating SPF 30 by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quiest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

INDICATIONS & USAGE

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

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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	10 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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Benzyl Alcohol (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Chlorphenesin (UNII: I670DAL4SZ)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexyl Palmitate (UNII: 2865993309)
Glycerin (UNII: PDC6A3C0OX)
Oleth-3 (UNII: BQZ26235UC)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
Sorbitol (UNII: 506T60A25R)
Tocopherol (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1124-06	236 mL in 1 TUBE; Type 0: Not a Combination Product	11/16/2016
2	NDC: 0363-1124-03	89 mL in 1 TUBE; Type 0: Not a Combination Product	11/16/2016
3	NDC: 0363-1124-07	296 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(0363-1124) , label(0363-1124)