SPF 30 SUNSCREEN- zinc oxide lotion

SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Salt and Stone LLC, WILD CHILD W A PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Non-Nano Zinc Oxide 22%

Purpose

Sunscreen

Uses

• 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

Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Caprilic capric triglyceride, Cyclomethicone, Cetearyl Alcohol, Cetearyl Glucoside, Glycerol, Phenoxyethanol, Ethylhexylglycerin, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Naturally Derived Vanilla fragrance, Xanthan gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF 30 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71585-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISOSTEARIC ACID (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE (UNII: NMQ347994Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71585-110-00	88 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - Salt and Stone LLC (080683697)

Establishment
Name	Address	ID/FEI	Business Operations
WILD CHILD W A PTY LTD		744660692	manufacture(71585-110)