SPF 50 SUNSCREEN- zinc oxide stick

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

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Active ingredient:
Non-Nano Zinc Oxide 22.5%, Sunscreen
Available from:
Salt and Stone LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Helps prevent sunburn - If used as directed with other sun protection measures ( see directions ) decreases the risk of skin cancer and early skin aging caused by the sun.
Authorization status:
OTC monograph not final
Authorization number:
71585-115-00

SPF 50 SUNSCREEN- zinc oxide stick

Salt and Stone LLC

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 50 Sunscreen Stick

Drug Facts

Active Ingredients

Non-Nano Zinc Oxide 22.5%

Purpos e

Sunscreen

Us es

Helps prevent sunburn

If used as directed with other sun protection measures ( see directions) decreases the risk of skin

cancer and early skin aging caused by the sun.

Warnings

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 occurs.

Keep out of reach of children.

If product is 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

Immediately after towel drying

At least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin

aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher &

other sun protection measures including:

Limit time in the sun, especially from 10am - 2pm.

Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Cera Alba

(Beeswax)*,Butyrospermum Parkii (Shea) Butter*, Silica, Copernicia Cerifera (Carnauba) Wax*,

Theobroma Cacao (Cocoa) Seed Butter*, Mica, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol

(Vitamin E), Iron Oxides. *Organic

Package Labeling:

SPF 50 SUNSCREEN

zinc oxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7158 5-115

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Salt and Stone LLC

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

ZINC CATION

225 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

SHEA BUTTER (UNII: K49 155WL9 Y)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CO CO A BUTTER (UNII: 512OYT1CRR)

MICA (UNII: V8 A1AW0 8 8 0 )

JO JO BA O IL (UNII: 724GKU717M)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7158 5-115-0 0

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

0 4/0 1/20 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 no t final

pa rt352

0 4/0 1/20 19

Labeler -

Salt and Stone LLC (080683697)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Filltech USA, LLC

9 26 4338 55

ma nufa c ture (7158 5-115)

Revised: 5/2019

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