SUNNY SKIN GLOW FILTER SPF50- zinc oxide cream 
MCDONALD MULTINATIONAL PTY LTD

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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Active ingredient

Zinc Oxide 22.75%

Purpose

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.

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

image description

SUNNY SKIN GLOW FILTER SPF50 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83070-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83070-002-011 in 1 BOX10/27/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/27/2022
Labeler - MCDONALD MULTINATIONAL PTY LTD (746817764)

Revised: 10/2022
Document Id: ec0a8e4e-cfd4-4aec-e053-2995a90a23c5
Set id: 8f338854-1bcf-4dc4-8da2-46c3033fa042
Version: 2
Effective Time: 20221027
 
MCDONALD MULTINATIONAL PTY LTD