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

ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM by

Drug Labeling and Warnings

ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by NAKED SUNDAY PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

WHEN USING

keep out of eyes, Rinse with water to remove

Stop use & ask 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 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

OTHER SAFETY INFORMATION

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

Dosage and Administration

For External use Only, Apply over skin

Label

INGREDIENTS AND APPEARANCE

ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM 
avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81104-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81104-900-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022
2	NDC: 81104-900-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2022

Labeler - NAKED SUNDAY PTY LTD (746918845)