TRIPLE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40- sunscreen lotion

Triple Defense Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Triple Defense Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Rothschild Beauty Group LLC, TAKA USA Inc. dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 3.3%

Zinc Oxide 8.8%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides high protection against sunburn

Warnings

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 lasts.

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

o Immediately after towel drying

o At least every 2 hours

Children under 6 months of age: ask a doctor

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 am to 2 pm

wear long-sleeved shirts, pants, hats and sunglasses

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Alkyl (C12-15) Benzoate, Alpha Lipoic Acid, Artemisia Capillaris Flower, Butylene Glycol, Caprylyl Glycol, Chia Seed, Cyclomethicone, Diatomaceous Earth, Dimethicone, Dunaliella Salina, Ethylhexylglycerin, Fragrance, Glycerin, Haematococcus Pluvialis, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Galactoarabinan, Green Tea Leaf, Karum Seed Oil, Mannitol, Matricaria Chamomilla Whole, Oleth-10, Phenoxyethanol, Phymatolithon Calcareum, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid (2300 MW), Polysorbate 20, Polysorbate 60, Propanediol, Propanediol Dicaprylate, Silicon Dioxide, Sodium Phosphate, Sorbitol, Tetrahexyldecyl Ascorbate, Trehalose, Triethoxycaprylylsilane, Water, Xylitol, Zinc Sulfate

Tube and Carton label

INGREDIENTS AND APPEARANCE

TRIPLE DEFENSE SUNSCREEN BROAD SPECTRUM SPF 40 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73040-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	88 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	33 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
ZINC SULFATE (UNII: 89DS0H96TB)
TREHALOSE (UNII: B8WCK70T7I)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
KARUM SEED OIL (UNII: 62160PU6FJ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GALACTOARABINAN (UNII: SL4SX1O487)
PROPANEDIOL (UNII: 5965N8W85T)
PROPANEDIOL DICAPRYLATE (UNII: C577OMC6UH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MANNITOL (UNII: 3OWL53L36A)
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
OLETH-10 (UNII: JD797EF70J)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SORBITOL (UNII: 506T60A25R)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARTEMISIA CAPILLARIS FLOWER (UNII: KG4724BPZG)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALPHA LIPOIC ACID (UNII: 73Y7P0K73Y)
CHIA SEED (UNII: NU0OLX06F8)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73040-001-01	1 in 1 CARTON	11/13/2020
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/13/2020

Labeler - Rothschild Beauty Group LLC (062783354)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc. dba Cosmetic Innovations		802860515	manufacture(73040-001)