Label: BABO BABY SKIN MINERAL SUNSCREEN FF- mineral sunscreen spray
- NDC Code(s): 79265-8579-6
- 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 January 31, 2022
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- Official Label (Printer Friendly)
- SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF
- Active Ingredient
- Uses
- Purpose
- Warnings
- Do not use
- When using this product
- Stop use and ask doctor
- KEEP OUT OF REACH OF CHILDREN
-
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.
Sun Protection Measures• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.
Children under 6 months; ask a doctor.
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Inactive Ingredients
BENTONITE
BISABOLOL*
BUTYLOCTYL SALICYLATE
CALENDULA OFFICINALIS FLOWER EXTRACT*
CAPRYLHYDROXAMIC ACID
CAPRYLIC/CAPRIC TRIGLYCERIDE
CAPRYLYL GLYCOL
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL
CELLULOSE GUM
CETEARYL ALCOHOL
CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*
COCO GLUCOSIDE
GLYCERIN*
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*
JOJOBA ESTERS
METHYL DIHYDROABIETATE
MICROCRYSTALLINE CELLULOSE
NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*
POLYHYDROXYSTEARIC ACID
PROPANEDIOL
PUERARIA LOBATA (KUDZU) ROOT EXTRACT*
SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*
TETRADECANE
TOCOPHEROL
WATER (AQUA) - Other information
- Questions and comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BABO BABY SKIN MINERAL SUNSCREEN FF
mineral sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8579 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 mL Inactive Ingredients Ingredient Name Strength PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.00015 mL in 100 mL TETRADECANE (UNII: 03LY784Y58) 5 mL in 100 mL WATER (UNII: 059QF0KO0R) 53.8608 mL in 100 mL BENTONITE (UNII: A3N5ZCN45C) 1.5 mL in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL in 100 mL LEVOMENOL (UNII: 24WE03BX2T) 0.3 mL in 100 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.105 mL in 100 mL CHAMOMILE (UNII: FGL3685T2X) 0.00015 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.15845 mL in 100 mL SUNFLOWER OIL (UNII: 3W1JG795YI) 6 mL in 100 mL HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.38 mL in 100 mL METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 2 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 1 mL in 100 mL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 0.09 mL in 100 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 5 mL in 100 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.00015 mL in 100 mL CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL in 100 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3 mL in 100 mL SAFFLOWER OIL (UNII: 65UEH262IS) 3 mL in 100 mL COCO GLUCOSIDE (UNII: ICS790225B) 0.595 mL in 100 mL MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 0.66 mL in 100 mL NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.00015 mL in 100 mL POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 0.25 mL in 100 mL FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.00015 mL in 100 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.75 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8579-6 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 11/01/2020 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)
