BABO BOTANICALS SUPER SHIELD MINERAL SUNSCREEN SPF50- zinc oxide, titanium dioxide aerosol, spray

SPF 50 Sheer Mineral Sensitive Sunscreen by

Drug Labeling and Warnings

SPF 50 Sheer Mineral Sensitive Sunscreen 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 ingredients

Titanium Dioxide 4.3%
Zinc Oxide 14.7%

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.

• Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

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
• Hold container 4 to 6 inches from the skin to apply
• Apply liberally 15 minutes before sun exposure
• Do not spray directly into face
• Spray into hands and then apply to 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), Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Glycerin, Bisabolol*, Tocopherol, Bentonite, Caprylyl Glycol, Coco-Glucoside, Citric Acid, Sodium Gluconate, Cellulose Gum, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Caprylhydroxamic Acid, Polyhydroxystearic Acid, Alumina, Silica.

*Certified Organic Ingredients

Questions or comments?

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

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SUPER SHIELD MINERAL SUNSCREEN SPF50 
zinc oxide, titanium dioxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-7978
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	147 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	43 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERIN (UNII: PDC6A3C0OX)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
SODIUM GLUCONATE (UNII: R6Q3791S76)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEVOMENOL (UNII: 24WE03BX2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
ALUMINUM OXIDE (UNII: LMI26O6933)
BENTONITE (UNII: A3N5ZCN45C)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CHAMOMILE (UNII: FGL3685T2X)
COCONUT OIL (UNII: Q9L0O73W7L)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
OLIVE OIL (UNII: 6UYK2W1W1E)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-7978-1	177 mL in 1 CAN; Type 0: Not a Combination Product	10/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/30/2023

Labeler - Babo Botanicals, Inc. (058258734)