BABO BABY FACE MINERAL SUNSCREEN- mineral sunscreen stick

Babo Baby Face Mineral Sunscreen by

Drug Labeling and Warnings

Babo Baby Face Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Panel

Baby Face Mineral Sunscreen

Sheer & Gentle

Broad Spectrum SPF 50

70% Organic Ingredients

Water Resistant (80 Minutes)

Zinc Oxide Mineral Sunscreen

Fragrance Free

Net Wt 0.6 oz / 17 g

DRUG FACTS PANEL

Drug Facts Panel

Active Ingredient

Active Ingredient: Zinc Oxide Purpose: Sunscreen

Purpose

Sunscreen

Use

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 doctor if rash occurs. | Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away. May stain some fabrics and surfaces.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

• Apply liberally to exposed areas 15 minutes before sun exposure. Children under 6 months: Ask a doctor.
• Reapply:
• after 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 of 15 or higher and other protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Olivate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Tocopherol (Vitamin E).

*Certified Organic Ingredients

Distributed by

Dist: by Babo Botanicals, Inc.
60 East 56th Street New York, NY 10022

Package Labeling

INGREDIENTS AND APPEARANCE

BABO BABY FACE MINERAL SUNSCREEN 
mineral sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.267 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TAMANU OIL (UNII: JT3LVK84A1)	0.01 mL  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	7.5 mL  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.75 mL  in 100 g
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)	0.833 mL  in 100 g
ORYZANOL (UNII: SST9XCL51M)	3 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	6 mL  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.0005 mL  in 100 g
LEVOMENOL (UNII: 24WE03BX2T)	0.2 mL  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.0005 mL  in 100 g
CANDELILLA WAX (UNII: WL0328HX19)	9.5 mL  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1 mL  in 100 g
RICE BRAN OIL (UNII: LZO6K1506A)	24.09 mL  in 100 g
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)	8.75 mL  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.0005 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	3 mL  in 100 g
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)	0.01 mL  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	0.098 mL  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1)	15 mL  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.0005 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8065-1	1 in 1 CARTON	11/01/2020
1		17 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 Drug	M020	11/01/2020	01/31/2027

Labeler - Babo Botanicals, Inc. (058258734)