BABO BABY FACE MINERAL SUNSCREEN- mineral sunscreen stick 
Babo Botanicals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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8065 Babo Baby Face SPF 50 Mineral Sunscreen Stick

Principal Display Panel

Baby Face Mineral Sunscreen

Sheer & Gentle

Broad Spectrum SPF 50

70% Organic Ingredients

Water Resistant (80 Minutes)

Zinc Oxide Mineral Sunscreen

Fragrance Free

Net Wt 0.6 oz / 17 g

DRUG FACTS PANEL

Drug Facts Panel

Active Ingredient

Active Ingredient: Zinc Oxide Purpose: Sunscreen

Purpose

Sunscreen

Use

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 doctor if rash occurs. | Keep out of reach of children. If swallowed get medical help or contact a Poison Control center right away. May stain some fabrics and surfaces.

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

Other information

Inactive ingredients

Oryza Sativa (Rice) Bran Oil*, Persea Gratissima (Avocado) Oil*, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Olivate, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Theobroma Cacao (Cocoa) Seed Butter*, Oryzanol, Jojoba Esters, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Calophyllum Inophyllum (Tamanu) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Tocopherol (Vitamin E).

*Certified Organic Ingredients

Distributed by

Dist: by Babo Botanicals, Inc.
60 East 56th Street New York, NY 10022

Package Labeling

8065

BABO BABY FACE MINERAL SUNSCREEN 
mineral sunscreen stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.267 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TAMANU OIL (UNII: JT3LVK84A1) 0.01 mL  in 100 g
JOJOBA OIL (UNII: 724GKU717M) 7.5 mL  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL  in 100 g
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.833 mL  in 100 g
ORYZANOL (UNII: SST9XCL51M) 3 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F) 6 mL  in 100 g
CHAMOMILE (UNII: FGL3685T2X) 0.0005 mL  in 100 g
LEVOMENOL (UNII: 24WE03BX2T) 0.2 mL  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.0005 mL  in 100 g
CANDELILLA WAX (UNII: WL0328HX19) 9.5 mL  in 100 g
SHEA BUTTER (UNII: K49155WL9Y) 1 mL  in 100 g
RICE BRAN OIL (UNII: LZO6K1506A) 24.09 mL  in 100 g
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) 8.75 mL  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.0005 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR) 3 mL  in 100 g
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) 0.01 mL  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI) 0.098 mL  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1) 15 mL  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.0005 mL  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79265-8065-11 in 1 CARTON11/01/2020
117 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02011/01/2020
Labeler - Babo Botanicals, Inc. (058258734)

Revised: 11/2022
Document Id: ed79dde0-24fa-030c-e053-2a95a90a2e97
Set id: b131664d-1ad2-0a2f-e053-2995a90acbda
Version: 6
Effective Time: 20221114
 
Babo Botanicals, Inc.