EXTREME PROTECT SPF 30- octinoxate, zinc oxide lotion

EXTREME PROTECT SPF 30 by

Drug Labeling and Warnings

EXTREME PROTECT SPF 30 by is a Otc medication manufactured, distributed, or labeled by SCIENCE OF SKINCARE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate – 5.50%

Zinc Oxide – 4.12%

PURPOSE

SUNSCREEN

USES

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

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.

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

Use a water resistant sunscreen if swimming or sweating

Reapply 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 of 15 or higher and other sun protection measures including:
o limit time in the sun, especially from 10 a.m.-2 p.m.
o wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Questions or Comments?

Call Customer Care at (888) 804-4447

Inactive Ingredients

Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTREME PROTECT SPF 30 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69219-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCOL STEARATE SE (UNII: 6YLY96TQL6)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASIATICOSIDE (UNII: PKO39VY215)
ASIATIC ACID (UNII: 9PA5A687X5)
MADECASSIC ACID (UNII: M7O1N24J82)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69219-103-51	1 in 1 BOX	10/01/2014
1	NDC: 69219-103-13	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 69219-103-55	1 in 1 BOX	10/01/2014
2	NDC: 69219-103-15	5 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 69219-103-28	240 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2014

Labeler - SCIENCE OF SKINCARE LLC (006251958)