FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Peer Pharm Ltd.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:19

Label at a glance#

ProductBotao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and 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

Dosage and administration

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 tim...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • 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

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1508-1Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 501 in 1 CARTONSTICK12
69435-1508-1Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 5015 g in 1 TUBESTICK152

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-150869435-1508-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCO-CAPRYLATE4828G836N6IACT
CERESINQ1LS2UJO3AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
JOJOBA OIL724GKU717MIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHAMOMILEFGL3685T2XIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Botao - Grow Naturally Mineral Sunscreen Clear Facial Stick For Babies and Kids SPF 50ZINC OXIDEPeer Pharm Ltd.75763dc1-c762-42fc-a8fe-4d9d7bde0ce62026-01-12WarningsExact identifier
ndc (package): 69435-1508-1
ndc (product): 69435-1508
ndc11 (package): 69435150801
spl id: 48300008-7e84-ed20-e063-6294a90a06ff
spl set id: 75763dc1-c762-42fc-a8fe-4d9d7bde0ce6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.