BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF30- zinc oxide spray

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30 by

Drug Labeling and Warnings

Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30 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 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

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

*Certified Organic Ingredients

Questions or comments?

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

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF30 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-9758
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
TETRADECANE (UNII: 03LY784Y58)
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCO GLUCOSIDE (UNII: ICS790225B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-9758-1	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/26/2023

Labeler - Babo Botanicals, Inc. (058258734)