SUNNY SKIN SUPER SUN SPF50- zinc oxide cream

Sunny Skin Super Sun SPF50 by

Drug Labeling and Warnings

Sunny Skin Super Sun SPF50 by is a Otc medication manufactured, distributed, or labeled by MCDONALD MULTINATIONAL PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 22.75%

Purpose

Mineral Sunscreen

Uses

Help Prevent Sunburn. If uses as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early 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 doctor is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.

KEEP OUT OF REACH OF CHILDREN

Directions

For sunscreen use: apply liberally 15 mins before sun exposure apply to all skin exposed to the sun use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours.
Children under 6 months old of age: ask 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 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

MediumChain(Caprylic/capric) triglycerides, Castor (Ricinus communis) Seed Oil, Coco-octanoate (Coco-caprylate/caprate), Coconut (Cocos nucifera) Oil, Candellila wax, Hydrogenated castor oil, polyglyceryl-3 polyricinoleate, Tocopheryl acetate, Iron oxides, isostearic acid, IBR-TCLC in Jojoba Oil 0705 (Simmondsia Chinensis (Jojoba) Seed Oil (and) Squalane (and) Solanum Lycopersicum (Tomato) Fruit Extract).

Other information

protect this product from excessive heat and direct sun.

Questions or Comments?
Email hello@sunnyskin.com

Product label

INGREDIENTS AND APPEARANCE

SUNNY SKIN SUPER SUN SPF50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83070-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CASTOR OIL (UNII: D5340Y2I9G)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
CANDELILLA WAX (UNII: WL0328HX19)
COCONUT OIL (UNII: Q9L0O73W7L)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
JOJOBA OIL (UNII: 724GKU717M)
SOLANUM LYCOCARPUM FRUIT (UNII: GL29VWX729)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83070-001-01	1 in 1 BOX	10/27/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/27/2022

Labeler - MCDONALD MULTINATIONAL PTY LTD (746817764)