SPF 50 TINTED FACE MINERAL FRAGRANCE FREE 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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8068 Babo Botanicals SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

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

Primary container labeling

DRUG FACTS PANEL

79265-8068-0

Drug Facts Panel

Drug Facts Panel 2

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

INFORMATION PANEL

Principal Display Panel

0.6 oz. 17 g 79265-8068-0

Outer Package Box

SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN 
mineral sunscreen stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.2115 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79265-8068-01 in 1 BOX11/01/2020
1NDC:79265-8068-117 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2020
Labeler - Babo Botanicals, Inc. (058258734)
Registrant - Bell International Laboratories (967781555)
Establishment
NameAddressID/FEIBusiness Operations
Bell International Laboratories967781555manufacture(79265-8068)

Revised: 10/2021
Document Id: ceae1d5f-8a14-645c-e053-2a95a90a88f5
Set id: b20d4019-643b-60fe-e053-2a95a90a8729
Version: 2
Effective Time: 20211019
 
Babo Botanicals, Inc.