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

SPF 50 Stay Put Sunscreen by

Drug Labeling and Warnings

SPF 50 Stay Put Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sawyer Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70392-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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 DICAPRYLATE (UNII: 581437HWX2)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70392-014-01	1 in 1 CARTON
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/14/2016

Labeler - Sawyer Products (118285923)