EXTREME PROTECT SPF 40 ALL SHADES- zinc oxide, titanium dioxide cream

Extreme Protect SPF 40 by

Drug Labeling and Warnings

Extreme Protect SPF 40 by is a Otc medication manufactured, distributed, or labeled by Science of Skincare, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide: 15.3%

Titanium Dioxide: 1.3%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

Reapply:

After 40 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 10am - 2pm.

wear long-sleeve shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

Call Customer Care at (888) 804 - 4447

INACTIVE INGREDIENT

Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTREME PROTECT SPF 40  ALL SHADES
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69219-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
MADECASSIC ACID (UNII: M7O1N24J82)
DIMETHICONE 100 (UNII: RO266O364U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
ASIATICOSIDE (UNII: PKO39VY215)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ASIATIC ACID (UNII: 9PA5A687X5)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69219-108-11	1 in 1 BOX	04/01/2021
1	NDC: 69219-108-01	100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 69219-108-21	1 in 1 BAG	03/02/2021
2	NDC: 69219-108-02	5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 69219-108-03	240 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2021
4	NDC: 69219-108-01	100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2021
5	NDC: 69219-108-31	1 in 1 BOX	03/01/2021
5	NDC: 69219-108-03	240 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2021

Labeler - Science of Skincare, LLC. (006251958)