SUNNY SAILOR CAPTAIN S CLASSIC CLEAR MINERAL SUNSCREEN SPF 40- zinc oxide cream

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 by

Drug Labeling and Warnings

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by SUNNY SAILOR LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 22.50%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

• Higher SPF gives more sunburn protection

• Retains SPF after 80 minutes of swimming or sweating

• 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.
• Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask health professional before use.

Directions

• 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 10a.m.- 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

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

Inactive Ingredients

Beeswax*, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract*, Chamomila Recutita (Matricaria) Flower Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Hippophae Rhamnoides Oil*, Olea Europea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopheryl Acetate.

* Indicates Certified Organic Ingredients

Questions

(954) 466-1933

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNNY SAILOR CAPTAIN S CLASSIC CLEAR MINERAL SUNSCREEN SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85135-577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	225 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85135-577-00	100.55 mL in 1 TUBE; Type 0: Not a Combination Product	12/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/17/2024

Labeler - SUNNY SAILOR LLC (119411558)