BABO BOTANICALS DAILY SHEER TINTED MINERAL SUNSCREEN SPF 50- zinc oxide stick

Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc., Bell International Laboratories. 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 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*, Oryzanol, Theobroma Cacao (Cocoa) Seed Butter*, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Helianthus Annuus (Sunflower) Seed Oil, Octyldodecanol, Bisabolol*, Tocopherol, Calophyllum Inophyllum Seed Oil*, Argania Spinosa Kernel Extract, Hippophae Rhamnoides Fruit Extract, Rosa Canina Fruit Extract, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Coffea Arabica (Coffee) Seed Extract, Trihydroxystearin, Iron Oxides.

*CERTIFIED ORGANIC INGREDIENTS

Questions or comments?

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

Product Labeling

INGREDIENTS AND APPEARANCE

BABO BOTANICALS DAILY SHEER TINTED MINERAL SUNSCREEN SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8608
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
FERROUS OXIDE (UNII: G7036X8B5H)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)
TOCOPHEROL (UNII: R0ZB2556P8)
AVOCADO OIL (UNII: 6VNO72PFC1)
RICE BRAN OIL (UNII: LZO6K1506A)
CANDELILLA WAX (UNII: WL0328HX19)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SHEA BUTTER (UNII: K49155WL9Y)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
CHAMOMILE (UNII: FGL3685T2X)
BEESWAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
OCTYLDODECANOL (UNII: 461N1O614Y)
ORYZANOL (UNII: SST9XCL51M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8608-1	1 in 1 CARTON	12/17/2024
1		17 g in 1 CONTAINER; 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	12/17/2024

Labeler - Babo Botanicals, Inc. (058258734)

Registrant - Bell International Laboratories (967781555)