BOTAO - GROW NATURALLY MINERAL SUNSCREEN CLEAR FACIAL STICK FOR BABIES AND KIDS SPF 50- zinc oxide stick

Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50 by

Drug Labeling and Warnings

Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50 by is a Otc medication manufactured, distributed, or labeled by Peer Pharm Ltd.. 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 useon damaged or broken skin
• When using this productkeep out of eyes. Rinse with water to remove
• Stop use and ask a doctor if rash occurs
• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

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 a doctor

• if rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right  away.

Directions

• apply liberally 15 minutes before sun exposure

reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 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:
limiting time in the sun, especially from 10 a.m to 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: ask a doctor.

KEEP OUT OF REACH OF CHILDREN

Other information

Protect this product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive ingredients

Caprylic/Capric Triglyceride, Coco-Caprylate, Ozokerite, Butyloctyl Salicylate, Polyhydroxystearic Acid, Tocopherol, Cocos Nucifera (Coonut) Oil, Triethoxycaprylylsilane, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Water (Aqua), Bisabolol, Butyrospermum Parkii (Shea) Butter, Calendula Offcinalis(Calendula) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract.

Questions or comments

Call 951-297-7976 or visit www.botaobaby.com

Product label

INGREDIENTS AND APPEARANCE

BOTAO - GROW NATURALLY MINERAL SUNSCREEN CLEAR FACIAL STICK FOR BABIES AND KIDS SPF 50 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69435-1508
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	24.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE (UNII: 4828G836N6)
CERESIN (UNII: Q1LS2UJO3A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69435-1508-1	1 in 1 CARTON	01/31/2024
1		15 g 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	01/31/2024

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Establishment
Name	Address	ID/FEI	Business Operations
Peer Pharm Ltd.		514678390	manufacture(69435-1508)