BABO SPF 30 SHEER ZINC SUNSCREEN- mineral sunscreen spray

Babo SPF 30 Sheer Zinc Sunscreen by

Drug Labeling and Warnings

Babo SPF 30 Sheer Zinc Sunscreen by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Zinc Oxide 12%

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. Rinse with water to remove.
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

• rash occurs.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Shake well before use Hold container 4 to 6 inches from the skin to apply Apply liberally 15 minutes before sun exposure Do not spray directly into face Do not spray in windy condition Use in well-ventilated area 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), Butyloctyl Salicylate, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Methyl Dihydroabietate, Aloe Barbadensis (Aloe Vera) Leaf Juice, 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*, Glycerin, Coco-Glucoside, Caprylyl Glycol, Caprylhydroxamic Acid, Cetearyl Alcohol.

Questions and comments?

Call 1-800-422-2987 Mon - Fri 9:00AM - 5:00PM EST

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

BABO SPF 30 SHEER ZINC SUNSCREEN 
mineral sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.222 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
COCO GLUCOSIDE (UNII: ICS790225B)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8097-6	177 mL in 1 CAN; Type 0: Not a Combination Product	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	11/01/2020

Labeler - Babo Botanicals, Inc. (058258734)