SUNSCREEN SPF 70- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% spray

Sunscreen SPF 70 by

Drug Labeling and Warnings

Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by Wegman, 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
high 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 away from face to avoid breathing it keep
out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.
Avoid spraying in eyes. Contents under pressure. Do not puncture or
incinerate. Do not store at temperatures above 120ºF

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions Spray liberally and spread evenly by hand 15 minutes
before sun exposure Reapply: after 80 minutes of swimming or sweating
immediately after towel drying at least every 2 hours 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 Children under 6 months: ask a doctor 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-sleeve shirts,
pants, hats, and sunglasses

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients

Acrylates/Octylacrylamide Copolymer,
Alcohol Denat., Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Diethylhexyl
Syringylidenemalonate, Fragrance, Glycerin

QUESTIONS

Questions or comments?
1-800-Wegmans(934-6267) Ext 5920
9am - 4pm EST weekdays.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 70 
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47124-115
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)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47124-115-05	170 g in 1 CAN; Type 0: Not a Combination Product	03/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/06/2013

Labeler - Wegman (059650069)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(47124-115) , label(47124-115)