REEF SAFE UNSCENTED SPF MINERAL SUNSCREEN 01- avobenzone,homosalate,octocrylene,octisalate cream

REEF SAFE Unscented SPF Mineral Sunscreen by

Drug Labeling and Warnings

REEF SAFE Unscented SPF 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

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF giwes more sunburn protection

Warnings

For external use only

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 only to prevent sumburn, not skin cancer or early skin aging.

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.

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 15minutes 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 decreases 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 10a.m.- 2p.m.
• wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients

AQUA(WATER), ISONONYL ISONONANOATE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CETETH-25, CETEARYL ALCOHOL, SILICA, VP/HEXADECENE COPOLYMER, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, TOCOPHEROL, XANTHAN GUM, PVP, ETHYLHEXYLGLYCERIN, GLYCINE MAX (SOYBEAN) OIL, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE

Other information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REEF SAFE UNSCENTED SPF MINERAL SUNSCREEN  01
avobenzone,homosalate,octocrylene,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
TOCOPHEROL (UNII: R0ZB2556P8)
PVP (UNII: FZ989GH94E)
GLYCINE MAX (SOYBEAN) OIL (UNII: 241ATL177A)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-25 (UNII: 5KLY4IOG20)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICA (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-027-01	45 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/03/2024

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(82953-027)