Drug Facts

Active ingredients:

Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 6.0%, Titanium Dioxide 2.6%

Purpose:

Sunscreen

Uses:

· Helps prevent sunburn.

Warnings:

Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
· For external use only.

Do not use

on broken or damaged skin.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

keep out of eyes. Rinse with warm water to remove.

Stop use and ask a doctor

if rash occurs.

Directions:

· Apply liberally to cool, dry skin 15 minutes before sun exposure.
· Use a water resistant sunscreen if swimming or sweating.
· Reapply at least every 2 hours.
· For children under 6 months of age: ask a doctor before using.

Other information:

· Protect this product container from excessive heat and direct sun.

Inactive ingredients:

Aloe Barbadensis Leaf Juice, Dicaprylyl Maleate, Neopentyl Glycol Diethylhexanoate (and) Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Phenoxyethanol (and) Methyl paraben (and) Ethylparaben (and) Butylparaben (and)
Propyl paraben (and) Isobutylparaben, Poly ethylene, Poly quaternium 37 (and) Propylene Glycol Dicaprylate/Dicaprate (and) PPG-1 Trideceth-6, Water

Package Labeling:

Outer Inner

SPF 50 STAY PUT SUNSCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70392-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIOCTYL MALEATE (UNII: OD88G8439L)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:70392-015-01	1 in 1 CARTON
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/15/2016

Labeler - Sawyer Products (118285923)

SPF 50 Stay Put Sunscreen