SPF 30 MINERAL SUN STICK- zinc oxide stick

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Raining Rose, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - Helps prevent sunburn - Do not use on damaged or broken skin Stop use and as a doctor if • rash occurs
Authorization status:
OTC monograph final
Authorization number:
65692-0848-1

SPF 30 MINERAL SUN STICK- zinc oxide stick

Raining Rose, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF 30 Mineral Sun Stick

DRUG FACTS

Active Ingredients:

Zinc Oxide 18.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For External Use Only

Do not use on damaged or broken skin

Stop use and as a doctor if rash occurs

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

Keep out of reach of children.

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

Directions 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

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 protection measures including:

limit time in the sun, especially from 10a.m. - 2p.m.

wear long sleeved shirts, pants, hat, and sunglasses.

Inactive Ingredients: Sunflower Seed Oil*, Beeswax*, Olive Oil*, Tocopherol,

aloe vera leaf extract, canola oil. *Organic Ingredient

Other Information: Protect this product from excessive heat and direct sun.

Product Package Labeling

PEEL HERE FOR DRUG FACTS

Broad Spectrum

SPF 30 Mineral Sun Stick

Made in the USA

Net Wt. 0.6.oz.

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

L000000

SAFETY SEAL

SPF 30 MINERAL SUN STICK

Raining Rose, Inc.

zinc oxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 56 9 2-0 8 48

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

3.0 6 g in 17 g

Inactive Ingredients

Ingredient Name

Stre ng th

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

O LIVE O IL (UNII: 6 UYK2W1W1E)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CANO LA O IL (UNII: 331KBJ17RK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 56 9 2-0 8 48 -1

17 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /21/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 8 /21/20 19

Labeler -

Raining Rose, Inc. (083819404)

Registrant -

Raining Rose, Inc. (083819404)

Revised: 8/2019

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