CHAE ORGANICS SAFE4U SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL MINERAL SUNSCREEN- zinc oxide cream

Chae ORGANICS SAFE4U Sunscreen Broad Spectrum SPF 30 Natural Mineral Sunscreen by

Drug Labeling and Warnings

Chae ORGANICS SAFE4U Sunscreen Broad Spectrum SPF 30 Natural Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Chae Organics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20%

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 ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For sunscreen use
Apply liberally 15 minutes before sun exposure
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 broad spectrum SPF of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. – 2 p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating

Other information:

Protect this product from excessive heat and direct sun

Inactive Ingredients:

Aloe Barbadensis Leaf Juice*, Benzoic Acid, Benzyl Alcohol, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Coco-Caprylate, Cucumis Sativus Fruit Extract*, Dehydroacetic Acid, Dicaprylyl Carbonate, Dl Panthenol, Ectoin, Glycerin, Helianthus Annuus Seed Oil*, Lauryl Glucoside Polyglyceryl-2 Dipolyhydroxystearate, Microcrystalline Cellulose, Phytic Acid, Polyhydroxystearic Acid, Sambucus Nigra Flower Extract*, Symphytum Officinale Leaf Extract*, Terminalia Ferdinandiana Fruit Extract, Tocopherol, Tocopheryl Acetate, Water, Withania Somnifera Root Extract*, Xanthan Gum. *Organic

Package Labeling:

INGREDIENTS AND APPEARANCE

CHAE ORGANICS SAFE4U SUNSCREEN BROAD SPECTRUM SPF 30 NATURAL MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72434-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCO-CAPRYLATE (UNII: 4828G836N6)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PANTHENOL (UNII: WV9CM0O67Z)
ECTOINE (UNII: 7GXZ3858RY)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FYTIC ACID (UNII: 7IGF0S7R8I)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72434-001-02	57 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2019

Labeler - Chae Manufacturing (074439626)