Babo Botanicals Daily Sheer Mineral Sunscreen for Face SPF 40

Babo Botanicals Daily Sheer Mineral Sunscreen for Face SPF 40 by

Drug Labeling and Warnings

Babo Botanicals Daily Sheer Mineral Sunscreen for Face SPF 40 by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN FOR FACE SPF 40- titanium dioxide, zinc oxide lotion 
Babo Botanicals, Inc.

----------

Babo Botanicals Daily Sheer Mineral Sunscreen for Face SPF 40

Drug Facts

Active Ingredients

Titanium Dioxide (Non-Nano) 1.9%

Zinc Oxide (Non-Nano) 15.9%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection easures ( 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 right away.

Directions

Apply liberally to exposed areas 15 minutes before sun exposure. Children under 6 months: ask a doctor.

• Use a water resistant sunscreen if swiming or sweating.
• Reapply:
• after 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 the 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 sleeves shirts, pants, hats, and sunglasses.

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.

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice*, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Calcium Sodium Borosilicate, Calendula Officinalis Flower Extract*, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil*, Erythritol*, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil*, Jojoba Esters, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Persea Gratissima (Avocado) Oil*, Polyhydroxystearic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Rubus Idaeus (Raspberry) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Sodium Gluconate, Sodium Stearoyl Glutamate, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Water (Aqua), Xanthan Gum.

*CERTIFIED ORGANIC INGREDIENTS

Company Information

Dist by Babo Botanicals, Inc.

60 East 56th Street New York, NY 10022

www.babobotanicals.com

MADE IN THE USA of US & imported materials.

Certified to NSF/ANSI 305 by Quality Assurance International

Product Packaging

BABO BOTANICALS DAILY SHEER MINERAL SUNSCREEN FOR FACE SPF 40 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	159 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
CHAMOMILE (UNII: FGL3685T2X)
LEVOMENOL (UNII: 24WE03BX2T)
DOCOSANOL (UNII: 9G1OE216XY)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
AVOCADO OIL (UNII: 6VNO72PFC1)
ROSEMARY (UNII: IJ67X351P9)
JOJOBA OIL (UNII: 724GKU717M)
ERYTHRITOL (UNII: RA96B954X6)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SUNFLOWER OIL (UNII: 3W1JG795YI)
RASPBERRY SEED OIL (UNII: 9S8867952A)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
COCO GLUCOSIDE (UNII: ICS790225B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8071-1	1 in 1 BOX	04/01/2022
1		50 mL in 1 TUBE; 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	04/01/2022	11/01/2023

Labeler - Babo Botanicals, Inc. (058258734)

Revised: 11/2023

Document Id: 0917a14a-5dda-f29b-e063-6394a90a18ab

34390-5

Set id: d66a2b8d-110a-6573-e053-2995a90a7198

Version: 2

Effective Time: 20231101