SPF 50 SHEER MINERAL SENSITIVE SUNSCREEN- mineral sunscreen 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]

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.

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. 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 doctor if

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

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), 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 (Vitamin E), 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 and comments?

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

SPF 50 Sheer Mineral Sensitive Spray Sunscreen

INGREDIENTS AND APPEARANCE

SPF 50 SHEER MINERAL SENSITIVE SUNSCREEN 
mineral sunscreen aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8797
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.65 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
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: 79265-8797-6	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 Drug	M020	11/01/2020	06/30/2024

Labeler - Babo Botanicals, Inc. (058258734)