BABO BOTANICALS DAILY SHEER FLUID TINTED MINERAL SUNSCREEN SPF 50- zinc oxide lotion

Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 by

Drug Labeling and Warnings

Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 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 20.6%

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 a 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
• Use water resistant sunscreen if swimming or sweating
• Reapply at least every two 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, Diheptyl Succinate, Calcium Sodium Borosilicate, Octyldodecyl Neopentanoate, Erythritol, Lauryl Laurate, Passiflora Edulis (Maracuja) Seed Oil, Propanediol, Carthamus Tinctorius (Safflower) Oleosomes, Bentonite, Aloe Barbadensis Leaf Juice*, Lupinus Albus (White Lupin) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil*, Bisabolol*, Tocopherol, Glycerin, 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*, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Hydrolyzed Wheat Protein/PVP Crosspolymer, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Sucrose Stearate, Coco-Glucoside, Octyldodecyl Oleate, Polyhydroxystearic Acid, Sodium Gluconate, Caprylhydroxamic Acid, Microcrystalline Cellulose, Xanthan Gum, Iron Oxides.

*Certified Organic Ingredients

Questions or comments?

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

Company Information

Dist by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

www.babobotanicals.com

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS DAILY SHEER FLUID TINTED MINERAL SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	206 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCROSE STEARATE (UNII: 274KW0O50M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
LAURYL LAURATE (UNII: GPW77G0937)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
PROPANEDIOL (UNII: 5965N8W85T)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
BENTONITE (UNII: A3N5ZCN45C)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LEVOMENOL (UNII: 24WE03BX2T)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHAMOMILE (UNII: FGL3685T2X)
LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q)
WHEAT GERM OIL UNSAPONIFIABLES (UNII: 6AXM7XCV3D)
TOCOPHEROL (UNII: R0ZB2556P8)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ETHYL FERULATE (UNII: 5B8915UELW)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
COCO GLUCOSIDE (UNII: ICS790225B)
ERYTHRITOL (UNII: RA96B954X6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8063-1	1 in 1 BOX	03/01/2022
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2022

Labeler - Babo Botanicals, Inc. (058258734)