HYDRATING SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% spray

Hydrating SPF 50 by

Drug Labeling and Warnings

Hydrating SPF 50 by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest 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 moderate protection against sunburn

WARNINGS

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

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. 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRATING SPF 50 
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1120
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1120-05	156 g in 1 CAN; Type 0: Not a Combination Product	11/16/2016
2	NDC: 0363-1120-06	283 g in 1 CAN; 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 Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(0363-1120) , label(0363-1120)