ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM- avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, oil 
NAKED SUNDAY PTY LTD

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NAKED SUNDAYS ANTIOXIDANT BODY SUNSCREEN CRÈME SPF 50 BROAD SPECTRUM

ACTIVE INGREDIENTS

AVOBENZONE 3 %

HOMOSALATE 10%

OCTISALATE 5 %

OCTOCRYLENE 10%

PURPOSE

SUNSCREEN

USE

- Helps prevents 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.

Skin Cancer/Skin Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging.
This product has been shown only to help prevent
sunburn, not skin cancer or early skin aging

keep out of eyes, Rinse with water to remove

Stop use & ask doctor

If rash occurs

If product is swallowed , get medical help or contact a poison control center right away

Directions

Apply generously 15 minutes before sun exposure.
Use a water-resistant sunscreen if 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 inclusing:

- limit time in the sun, especially from 10:00 AM- 02:00 PM

- Wear long- Sleeved shirts , pants, Hats and sunglasses

Inactive Ingredients

Inactive Ingredients:
Dimethicone, Ethylhexylglycerin, Fragrance, Gluconolactone,
Glyceryl Monostearate, Kakadu Plum, Phenoxyethanol,
Potassium Cetyl Phosphate, Purified Water, Sodium
Benzoate, Sodium Polyacrylate, Tocopherol acetate

Protect the product in this container from excessive heat & direct sun

Dosage and Administration

For External use Only, Apply over skin

Label

12

ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM 
avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-900
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81104-900-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
2NDC:81104-900-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2022
Labeler - NAKED SUNDAY PTY LTD (746918845)

Revised: 12/2023
Document Id: 0cb20a34-54fb-15e1-e063-6394a90a376b
Set id: eb7a84a8-3e25-9988-e053-2a95a90a58a9
Version: 4
Effective Time: 20231217
 
NAKED SUNDAY PTY LTD