MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM- zinc oxide lotion

MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM by

Drug Labeling and Warnings

MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by MOTHER SUN PROTECTION FACTOR PTY LTD, WILD CHILD W A PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE  19.5%

PURPOSE

SUNSCREEN

USE

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing 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.

DIRECTIONS

• Apply generously 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 10.00AM - 2.00PM
• Wear long-sleeved shirts, pants, hats, and sunglasses”

INACTIVE INGREDIENTS

Coco-Caprylate/Caprate (ECOCERT) (and) Polyglyceryl-3 Polyricinoleate (ECOCERT) (and) Isostearic Acid (ECOCERT), Caprilic Capric Triglyceride (SUSTAINABLY SOURCED), Coconut Oil (ACO), Castor Oil (ACO), Candellila Wax, Dl Alpha Tocopheryl Acetate (SUSTAINABLY SOURCED)

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.
For expiration date see crimp of tube.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73204-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
Isostearic Acid (UNII: X33R8U0062)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Coconut Oil (UNII: Q9L0O73W7L)
Castor Oil (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73204-101-11	120 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/01/2019

Labeler - MOTHER SUN PROTECTION FACTOR PTY LTD (745449142)

Establishment
Name	Address	ID/FEI	Business Operations
WILD CHILD W A PTY LTD		744660692	manufacture(73204-101)