BABO BABY SKIN MINERAL SUNSCREEN FF- mineral sunscreen spray

Babo Baby Skin Mineral Sunscreen FF by

Drug Labeling and Warnings

Babo Baby Skin Mineral Sunscreen FF by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF

This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

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

Purpose

Sunscreen

Warnings

For external use only.

Do not use

• on damaged or broken skin.

When using this product

Keep out of eye. Rinse with water to remove.

Stop use and ask doctor

if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

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. and wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months; ask a doctor.

Inactive Ingredients

BENTONITE
BISABOLOL*
BUTYLOCTYL SALICYLATE
CALENDULA OFFICINALIS FLOWER EXTRACT*
CAPRYLHYDROXAMIC ACID
CAPRYLIC/CAPRIC TRIGLYCERIDE
CAPRYLYL GLYCOL
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL
CELLULOSE GUM
CETEARYL ALCOHOL
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*
COCO GLUCOSIDE
GLYCERIN*
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*
JOJOBA ESTERS
METHYL DIHYDROABIETATE
MICROCRYSTALLINE CELLULOSE
NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*
POLYHYDROXYSTEARIC ACID
PROPANEDIOL
PUERARIA LOBATA (KUDZU) ROOT EXTRACT*
SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*
TETRADECANE
TOCOPHEROL
WATER (AQUA)

Other information

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Questions and comments

Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST

PRINCIPAL DISPLAY PANEL

79265-8579-6 6 fl. oz. / 177 mL

INGREDIENTS AND APPEARANCE

BABO BABY SKIN MINERAL SUNSCREEN FF 
mineral sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8579
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)	0.00015 mL  in 100 mL
TETRADECANE (UNII: 03LY784Y58)	5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	53.8608 mL  in 100 mL
BENTONITE (UNII: A3N5ZCN45C)	1.5 mL  in 100 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.7 mL  in 100 mL
LEVOMENOL (UNII: 24WE03BX2T)	0.3 mL  in 100 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.105 mL  in 100 mL
CHAMOMILE (UNII: FGL3685T2X)	0.00015 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.15845 mL  in 100 mL
SUNFLOWER OIL (UNII: 3W1JG795YI)	6 mL  in 100 mL
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)	0.38 mL  in 100 mL
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)	2 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T)	1 mL  in 100 mL
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)	0.09 mL  in 100 mL
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)	5 mL  in 100 mL
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.00015 mL  in 100 mL
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)	0.15 mL  in 100 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	3 mL  in 100 mL
SAFFLOWER OIL (UNII: 65UEH262IS)	3 mL  in 100 mL
COCO GLUCOSIDE (UNII: ICS790225B)	0.595 mL  in 100 mL
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)	0.66 mL  in 100 mL
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.00015 mL  in 100 mL
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)	0.25 mL  in 100 mL
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.00015 mL  in 100 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.75 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8579-6	177 mL in 1 BOTTLE, SPRAY; 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	part352	11/01/2020

Labeler - Babo Botanicals, Inc. (058258734)