Label: BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN BALM SPF 50- zinc oxide salve
- NDC Code(s): 79265-8776-1
- 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 April 6, 2023
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- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply after 80 minutes of swimming or sweating, immediately after towel-drying, at least every two hours.
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 sun protection measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months of age: ask a doctor
- Other information
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Inactive ingredients
Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Tapioca Starch, Saccharomyces Ferment, Behenyl Behenate, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Passiflora Edulis (Maracuja) Seed Oil, Bentonite, Butyrospermum Parkii (Shea) Butter, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Nasturtium Officinale (Watercress) Flower/Leaf Extract, Spiraea Ulmaria (Meadowsweet) Flower Extract, Lauroyl Lysine, Euphorbia Cerifera (Candelilla) Wax, Acacia Decurrens Flower Wax, Polyglyceryl-10 Diisosterate, Polyglycerin-3.
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INGREDIENTS AND APPEARANCE
BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN BALM SPF 50
zinc oxide salveProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79265-8776 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 245 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) BENTONITE (UNII: A3N5ZCN45C) SHEA BUTTER (UNII: K49155WL9Y) LAUROYL LYSINE (UNII: 113171Q70B) FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9) BEHENYL BEHENATE (UNII: K8NU647RJ0) CANDELILLA WAX (UNII: WL0328HX19) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) TOCOPHEROL (UNII: R0ZB2556P8) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) NASTURTIUM OFFICINALE (UNII: YH89GMV676) STARCH, TAPIOCA (UNII: 24SC3U704I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79265-8776-1 1 in 1 CARTON 04/02/2023 1 56 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 04/02/2023 Labeler - Babo Botanicals, Inc. (058258734)
