Label: BABO SPF 30 SHEER ZINC SUNSCREEN- mineral sunscreen spray
- Label RSS
- Share
- NDC Code(s): 79265-8097-6
- 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 November 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
-
Inactive ingredients
Aloe Barbadensis Leaf Juice
Bentonite
Butyloctyl Salicylate
Calendula Officinalis Flower Extract*
Caprylhydroxamic Acid
Caprylyl Glycol
Carthamus Tinctorius (Safflower) Seed Oil
Cetearyl Alcohol
Chamomilla Recutita (Matricaria) Flower Extract*
Coco Glucoside
Glycerin
Helianthus Annuus (Sunflower) Seed Oil
Heptyl Undecylenate
Jojoba Esters
Methyl Dihydroabietate
Nasturtium Officinale (Watercress) Flower/leaf Extract*
Pueraria Lobata (Kudzu) Root Extract*
Spiraea Ulmaria (Meadowsweet) Flower Extract*
Water (Aqua)*Certified Organic Ingredient
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BABO SPF 30 SHEER ZINC SUNSCREEN
mineral sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12.222 g in 100 mL Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.001 mL in 100 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 0.715 mL in 100 mL CHAMOMILE (UNII: FGL3685T2X) 0.001 mL in 100 mL SUNFLOWER OIL (UNII: 3W1JG795YI) 0.095 mL in 100 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 10 mL in 100 mL METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) 2 mL in 100 mL PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C) 0.001 mL in 100 mL FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) 0.001 mL in 100 mL BENTONITE (UNII: A3N5ZCN45C) 2.5 mL in 100 mL CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) 0.15 mL in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.7 mL in 100 mL WATER (UNII: 059QF0KO0R) 66.69 mL in 100 mL SAFFLOWER OIL (UNII: 65UEH262IS) 2 mL in 100 mL HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) 0.378 mL in 100 mL NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G) 0.001 mL in 100 mL COCO GLUCOSIDE (UNII: ICS790225B) 0.385 mL in 100 mL HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) 2 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.15 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8097-6 177 mL in 1 CAN; 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) Registrant - Bell International Laboratories (967781555) Establishment Name Address ID/FEI Business Operations Bell International Laboratories 967781555 manufacture(79265-8097)
