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
Drug Label Information
Updated December 12, 2024
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- 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 Drug M020 07/24/2020 Labeler - Babo Botanicals, Inc. (058258734)