BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN SPF 30- zinc oxide spray

Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 by

Drug Labeling and Warnings

Babo Botanicals Swim and Sport Mineral Sunscreen SPF 30 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 14.5%

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 immediately.

Directions

• Shake well
• Apply liberally 15 minutes before sun exposure.
• Reapply after 80 minutes of swimming or sweating, immediately after towel-drying, at least every two 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 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.
• Children under 6 months of age: ask a doctor

Other information

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

Inactive ingredients

Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Butyloctyl Salicylate, Tetradecane, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Bentonite, Cetearyl Alcohol, Propanediol, Passiflora Edulis (Maracuja) Seed Oil, Jojoba Esters, Tocopherol (Vitamin E), Glycerin, Bisabolol, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Microcrystalline Cellulose, Coco-Glucoside, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Cellulose Gum, Caprylyl Glycol.

Questions or comments?

Call 1-800-422-2987 M-F

9:00am - 5:00pm EST

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN SPF 30 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8775
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	145 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
JOJOBA OIL (UNII: 724GKU717M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
PROPANEDIOL (UNII: 5965N8W85T)
TETRADECANE (UNII: 03LY784Y58)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
COCO GLUCOSIDE (UNII: ICS790225B)
LEVOMENOL (UNII: 24WE03BX2T)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMOMILE (UNII: FGL3685T2X)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8775-1	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/02/2023

Labeler - Babo Botanicals, Inc. (058258734)