SPF 50 SUNSCREEN- zinc oxide stick

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Non-Nano Zinc Oxide 22.5%, Sunscreen

MAH:

Salt and Stone LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

- 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

SPC

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
B