BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN lotion

Broad Spectrum SPF 30 Tropical Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 30 Tropical Sunscreen by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc, Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

PURPOSE

Sunscreen

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product Keep out of eyes. Rinse well with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours
Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Aloe Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Pentylene Gycol, Potassium Sorbate, Propanediol, Soybean Oil, Sunflower Oil, Sweet Amond Oil, Tocopherol, Water, Xanthan Gum.

INDICATIONS & USAGE

Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN 
broad spectrum spf 30 tropical sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID (UNII: 2968PHW8QP)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)
PROPANEDIOL (UNII: 5965N8W85T)
SOYBEAN OIL (UNII: 241ATL177A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0590-1	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2025

Labeler - Raining Rose, Inc (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(65692-0590)