BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN BALM SPF 50- zinc oxide salve

Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 by

Drug Labeling and Warnings

Babo Botanicals Swim and Sport Mineral Sunscreen Balm SPF 50 by is a Otc medication manufactured, distributed, or labeled by Babo Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 24.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask doctor

• if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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

• Protect this product from excessive heat and direct sun.
• May stain some fabrics and surfaces.

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.

Questions or comments?

Call 1-800-422-2987 M-F

9:00am - 5:00pm EST

Product Packaging

INGREDIENTS AND APPEARANCE

BABO BOTANICALS SWIM AND SPORT MINERAL SUNSCREEN BALM SPF 50 
zinc oxide salve

Product 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)