BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50- zinc oxide stick

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 by

Drug Labeling and Warnings

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 19.7%

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 swallowed, get medical help or contact a Poison Control center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 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 of 15 or higher and other protection measures including:
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

Other information

• Protect this product from excessive heat and direct sun.
• May stain some fabrics and surfaces.

Inactive ingredients

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Oleate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Butyrospermum Parkii (Shea) Butter*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil*, 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*, Tocopherol.

*Certified Organic Ingredients

Company Information

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

Package Labeling

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-5608
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	197 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-5608-1	1 in 1 CARTON	10/25/2023
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	10/25/2023

Labeler - Babo Botanicals, Inc. (058258734)