SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN- mineral sunscreen stick

SPF 50 Tinted Face Mineral Fragrance Free Sunscreen by

Drug Labeling and Warnings

SPF 50 Tinted Face Mineral Fragrance Free Sunscreen by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc., Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Primary Container Label

79265-8068-1

DRUG FACTS PANEL

79265-8068-0

ACTIVE INGREDIENTS

Zinc Oxide 20.2115%

USES

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

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

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 A 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

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

ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN.

*CERTIFIED ORGANIC INGREDIENT

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS / COMMENTS?

Questions and comments: Call 1-877-537-BABO

INFORMATION PANEL

79265-8068-0 INFORMATION PANEL

Principal Display Panel

0.6 oz. 17 g 79265-8068-0

INGREDIENTS AND APPEARANCE

SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN 
mineral sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79265-8068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.2115 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.5362 mL  in 100 g
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)	0.0015 mL  in 100 g
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)	0.0015 mL  in 100 g
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)	0.00125 mL  in 100 g
SUNFLOWER OIL (UNII: 3W1JG795YI)	0.1875 mL  in 100 g
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)	0.0092 mL  in 100 g
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)	0.9023 mL  in 100 g
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)	0.0015 mL  in 100 g
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)	0.00125 mL  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	7.5 mL  in 100 g
COCOA BUTTER (UNII: 512OYT1CRR)	3 mL  in 100 g
ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)	0.00125 mL  in 100 g
TOCOPHEROL (UNII: R0ZB2556P8)	0.75 mL  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1)	15 mL  in 100 g
RICE BRAN OIL (UNII: LZO6K1506A)	23.07 mL  in 100 g
CANDELILLA WAX (UNII: WL0328HX19)	9.5 mL  in 100 g
ARABICA COFFEE BEAN (UNII: 3SW678MX72)	0.00125 mL  in 100 g
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)	8.75 mL  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)	0.0015 mL  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1 mL  in 100 g
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)	0.01 mL  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.0015 mL  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	6 mL  in 100 g
LEVOMENOL (UNII: 24WE03BX2T)	0.2 mL  in 100 g
OCTYLDODECANOL (UNII: 461N1O614Y)	0.3608 mL  in 100 g
ORYZANOL (UNII: SST9XCL51M)	3 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79265-8068-0	1 in 1 BOX	11/01/2020
1	NDC: 79265-8068-1	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 Drug	M020	11/01/2020	02/28/2026

Labeler - Babo Botanicals, Inc. (058258734)

Registrant - Bell International Laboratories (967781555)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(79265-8068)