Label: SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN- mineral sunscreen stick
- NDC Code(s): 79265-8068-0, 79265-8068-1
- Packager: Babo Botanicals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick
- Primary Container Label
- DRUG FACTS PANEL
- ACTIVE INGREDIENTS
- USES
- PURPOSE
-
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
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
-
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
- QUESTIONS / COMMENTS?
- INFORMATION PANEL
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SPF 50 TINTED FACE MINERAL FRAGRANCE FREE SUNSCREEN
mineral sunscreen stickProduct 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 final part352 11/01/2020 Labeler - Babo Botanicals, Inc. (058258734) Registrant - Bell International Laboratories (967781555) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(79265-8068)
