REEF SAFE UNSCENTED SPF 50 MINERAL SUNSCREEN 01- titanium dioxide, zinc oxide cream

Reef safe unscented SPF 50 mineral sunscreen by

Drug Labeling and Warnings

Reef safe unscented SPF 50 mineral sunscreen by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 3.2%

Zinc oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection.

WARNINGS

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown

For external use only.

Do not use

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 persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure as needed
• Children under 6 months of age: ask a doctor before use.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating

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 value 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

Inactive ingredients

Water, Dicaprylyl Ether, lsododecane, Propylene Glycol, Disiloxane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hdi/Trimethylol Hexyllactone Crosspolymer, Silica, Disteardimonium Hectorite, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Sorbitan lsostearate, Aluminum Hydroxide, Caprylyl Glycol, Dimethicone, Ethylhexylglycerin

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REEF SAFE UNSCENTED SPF 50 MINERAL SUNSCREEN  01
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
SILICA (UNII: ETJ7Z6XBU4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
DISILOXANE (UNII: D7M4659BPU)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-050-01	45 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/31/2026

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-050)