Label: BABO BOTANICALS SPF 30 DAILY SHEER TINTED SUNSCREEN - NATURAL GLOW- mineral sunscreen lotion
- NDC Code(s): 79265-8072-0, 79265-8072-1
- 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 January 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a sunscreen manufactured according to the 2009 Final Monograph
The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.
- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
Apply liberally15 minutes before sun exposure. Children under 6 months of age: Ask a doctor.
• use a water resistant sunscreen if swimming or sweating• reapply: • immediately after towel drying • at least every 2 hours
Sun Protection Measures
Sun exposure increases risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.
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Inactive ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice*, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Beeswax*, Butyrospermum Parkii (Shea) Butter*, C13-14 Alkyls Benzoate, Camellia Sinensis (Green Tea) Extract*, Caryodendron Orinocense (Kahai) Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Glycerin*, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil*, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hyaluronic Acid, Iron Oxides, Lecithin, Mangifera Indica (Mango) Butter, Punica Granatum (Pomegranate) Extract*, Rosmarinus Officinalis (Rosemary) Oil*, Saccharide Isomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
*Certified Organic ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BABO BOTANICALS SPF 30 DAILY SHEER TINTED SUNSCREEN - NATURAL GLOW
mineral sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3000 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3000 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 27.803 mL in 100 mL GREEN TEA LEAF (UNII: W2ZU1RY8B0) 0.2 mL in 100 mL ROSEMARY (UNII: IJ67X351P9) 0.05 mL in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.05 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 10 mL in 100 mL YELLOW WAX (UNII: 2ZA36H0S2V) 0.05 mL in 100 mL SHEA BUTTER (UNII: K49155WL9Y) 1 mL in 100 mL ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) 5.5 mL in 100 mL CARYODENDRON ORINOCENSE WHOLE (UNII: J2T2D81BHU) 0.1 mL in 100 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 5.5 mL in 100 mL GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) 1.5 mL in 100 mL COCONUT OIL (UNII: Q9L0O73W7L) 3 mL in 100 mL CUCUMBER SEED (UNII: BT3S9L53JK) 0.2 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) 0.45 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 10 mL in 100 mL DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 8.7 mL in 100 mL FERRIC OXIDE RED (UNII: 1K09F3G675) 1.547 mL in 100 mL LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) 3.5 mL in 100 mL MANGO (UNII: I629I3NR86) 0.25 mL in 100 mL SACCHARIDE ISOMERATE (UNII: W8K377W98I) 0.15 mL in 100 mL STEARIC ACID (UNII: 4ELV7Z65AP) 1 mL in 100 mL ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.1 mL in 100 mL SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.2 mL in 100 mL GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.45 mL in 100 mL ARGAN OIL (UNII: 4V59G5UW9X) 0.2 mL in 100 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2 mL in 100 mL SUNFLOWER OIL (UNII: 3W1JG795YI) 3 mL in 100 mL HYALURONIC ACID (UNII: S270N0TRQY) 0.1 mL in 100 mL HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741) 0.2 mL in 100 mL POMEGRANATE (UNII: 56687D1Z4D) 0.2 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8072-0 1 in 1 BOX 07/24/2020 1 NDC:79265-8072-1 50 mL in 1 TUBE; 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 07/24/2020 Labeler - Babo Botanicals, Inc. (058258734)
