FDA.reportPublic FDA data

Sunny Sailor First Mate Face Stick SPF 30

Manufacturer
SUNNY SAILOR LLC | Pure Source, LLC
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:41

Label at a glance#

ProductSunny Sailor First Mate Face Stick SPF 30
Active ingredientZINC OXIDE
Label structure7 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 and as needed. Children under 6 months of age: ask a doctor. 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

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 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 if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Olea Europaea (Olive) Fruit Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label CartonLabel Cartonimage 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85135-877-00Sunny Sailor First Mate Face Stick SPF 3015 mL in 1 APPLICATORSTICK151
85135-877-00Sunny Sailor First Mate Face Stick SPF 301 in 1 BOXSTICK11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85135-87785135-877-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLC8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e2025-05-28WarningsExact identifier
ndc (package): 85135-877-00
ndc (product): 85135-877
ndc11 (package): 85135087700
spl id: 35b5b261-b338-60cb-e063-6394a90a1ab1
spl set id: 8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e

Reported adverse events (FAERS/openFDA)#

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