BABO BOTANICALS SENSITIVE BABY MINERAL SUNSCREEN SPF50- zinc oxide lotion

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 20.0%

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

• 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, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Seed Oil, Methyl Dihydroabietate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*, Bisabolol*, Tocopherol, Cetyl Alcohol, Caprylyl Glycol, Coco-Glucoside, Behenyl Alcohol, Arachidyl Glucoside, Arachidyl Alcohol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Sodium Hyaluronate, Glycerin, 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 SPF50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8758
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CHAMOMILE (UNII: FGL3685T2X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
COCOA BUTTER (UNII: 512OYT1CRR)
SAFFLOWER OIL (UNII: 65UEH262IS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8758-1	89 mL in 1 TUBE; 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)