SUNSCREEN SPF 70- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% spray

Sunscreen SPF 70 by

Drug Labeling and Warnings

Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by Care One, 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
Oxybenzone 6%.................................................................................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.
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 temperature above 120°F

KEEP OUT OF REACH OF CHILDREN

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.

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

Questions? 1-877-846-9949

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 70 
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 6% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-338
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
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
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: 41520-338-05	160 g in 1 CAN; Type 0: Not a Combination Product	01/18/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/18/2013

Labeler - Care One (809183973)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(41520-338) , label(41520-338)