ENVIRON SUNCARE BROAD SPECTRUM SPF 30- titanium dioxide cream

ENVIRON SUNCARE BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

ENVIRON SUNCARE BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dermacare USA, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active Ingredients

Titanium Dioxide 8%

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

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult a physician

if irritation or rash develops.

Keep out of reach of children.

If swallowed, get medical attention or contact a poison control center immediately.

Directions:

Apply liberally 15 minutes before sun exposure.
Reapply
- at least every 2 hours. 
- immediately after swimming, sweating or towel drying.
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 rating of 15 or higher, along with other sun protection measures including:
- Limit time in the sun, especially between 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months, consult a physician.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green) Tea Extract, Cetyl Alcohol, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Hyaluronic Acid, C13-14 Isoparaffn, Laureth-7, Lecithin,  Leontopodium Alpinum (Edelweiss) Extract, Phenoxyethanol, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Squalane, Stearic Acid, Tetrasodium EDTA, Thymus Vulgaris (Thyme) Extract, Tocopheryl Acetate (Vitamin E), Ubiquinone (CoQ10), Xanthan Gum, Zemea (Corn) Propanediol.

Other Information

Protect this product from excessive heat and direct sunlight

Package Labeling:

INGREDIENTS AND APPEARANCE

ENVIRON SUNCARE BROAD SPECTRUM SPF 30 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72610-270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
HYALURONIC ACID (UNII: S270N0TRQY)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
THYME (UNII: CW657OBU4N)
UBIDECARENONE (UNII: EJ27X76M46)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72610-270-04	1 in 1 BOX	10/01/2018
1		113.4 g 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 not final	part352	10/01/2018

Labeler - Dermacare USA, Inc (140133732)