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

Hydrating SPF 50 by

Drug Labeling and Warnings

Hydrating SPF 50 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 15%..........................................................................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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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	15 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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1121-06	236 mL in 1 CAN; Type 0: Not a Combination Product	11/16/2016
2	NDC: 0363-1121-07	296 mL in 1 TUBE; Type 0: Not a Combination Product	11/16/2016
3	NDC: 0363-1121-03	89 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(0363-1121) , label(0363-1121)