BROAD SPECTRUM SPF 30 SUNSCREEN lotion

Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide (18.75%) Non-nanoparticle

Purpose:

Sunscreen

Uses:

• Helps prevent sunburn

Warnings:

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs
• When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply after 80 minutes of swimming or sweating
• Reapply immediately after towel drying
• Reapply at least every 2 hours
• Children under 6 months of age: Ask a doctor

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

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Sunflower Oil*, Beeswax*, Jojoba Oil*, Coconut Oil*, Tocopherol (Non-GMO). *Organic

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure

PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 30 Sunscreen

Natural Mineral Formula

Water Resistant

(80 minutes)

1.5 fl.oz./44 mL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 30 SUNSCREEN 
broad spectrum spf 30 sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0566
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.25 g  in 44 mL

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0566-1	44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/13/2021

Labeler - Raining Rose (083819404)

Registrant - Raining Rose (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	label(65692-0566) , manufacture(65692-0566)