SPF 50 SUPER SHIELD SPORT SUNSCREEN- mineral sunscreen stick

SPF 50 Super Shield Sport Sunscreen by

Drug Labeling and Warnings

SPF 50 Super Shield Sport Sunscreen by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Primary Container Labeling

79265-8098-1 17 g

79265-8098 SPF 50 Super Shield Sport Stick Sunscreen

Sunscreen product manufactured pursuant to the Final Monograph. Active ingredient Zinc Oxide.

Active Ingredient

Zinc Oxide 17.363%

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 eyes. Rinse with water to remove. Stop use and ask doctor if rash occurs. Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Do not use

on damaged or broken skin.

When using this product

When using this product Keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

Stop use and ask doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If a product is 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.

inactive Ingredients

BEESWAX*
BISABOLOL
BUTYROSPERMUM PARKII (SHEA) BUTTER*
CALOPHYLLUM TACAMAHACA SEED OIL*
CANNABIS SATIVA SEED OIL*
EUPHORBIA CERIFERA (CANDELILLA) WAX
JOJOBA ESTERS
OCTYLDODECYL OLEATE
ORYZA SATIVA (RICE) BRAN OIL*
ORYZANOL
PERSEA GRATISSIMA (AVOCADO) OIL*
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*
THEOBROMA CACAO (COCOA) SEED BUTTER*
TOCOPHEROL

*Certified Organic ingredient

Other Information

Other Information: Protect this product from excessive heat and direct sun

QUESTIONS/ COMMENTS?

Questions and comments?

Call 1-877-537-BABO

INFORMATION PANEL

DRUG FACTS PANEL

PRINCIPAL DISPLAY PANEL

79265-8098-0

Babo Botanicals

Super Shield Sport Stick

Broad Spectrum Sunscreen SPF 50

100% Zinc Oxide Active Ingredient

80 Minute Water & Sweat Resistant

Ultra Sheer & Hypoallergenic

Fragrance Free

INGREDIENTS AND APPEARANCE

SPF 50 SUPER SHIELD SPORT SUNSCREEN 
mineral sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.363 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)	1 mL  in 100 g
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	0.01 mL  in 100 g
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)	0.537 mL  in 100 g
RICE BRAN OIL (UNII: LZO6K1506A)	27.38 mL  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1)	15 mL  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	7.5 mL  in 100 g
ORYZANOL (UNII: SST9XCL51M)	3 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	6 mL  in 100 g
CANDELILLA WAX (UNII: WL0328HX19)	9.5 mL  in 100 g
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)	8.75 mL  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.75 mL  in 100 g
LEVOMENOL (UNII: 24WE03BX2T)	0.2 mL  in 100 g
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)	0.01 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	3 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8098-0	1 in 1 BOX	11/01/2020
1	NDC: 79265-8098-1	17 g in 1 CYLINDER; Type 0: Not a Combination Product

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)