GLOW GO LIP OIL SPF50- avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, (sunscreens) oil 
NAKED SUNDAY 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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NAKED SUNDAYS SPF50+ Glow + Go Lip Oil

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.

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 20 minutes before sun exposure

- Use a water resistant sunscreen if swimming or sweating

- Re-apply frequently especially after swimming excercising or towel drying

- Re-apply 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

Ingredients

Candelilla wax, Ethylhexylglycerin, Flavour, Isopropyl myristate, MICA, Octyldodecanol, Phenoxyethanol, Polybutene, Raspberry oil, Tomato extract, Watermelon oil

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

Label

1Label

GLOW GO LIP OIL  SPF50
avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, (sunscreens) oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81104-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
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
Inactive Ingredients
Ingredient NameStrength
CANDELILLA WAX (UNII: WL0328HX19)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MICA (UNII: V8A1AW0880)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
TOMATO EXTRACT CONTAINING LYCOPENE (UNII: N53I4V2IA6)  
WATERMELON SEED OIL (UNII: L33J06UQTT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81104-111-024.5 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2021
Labeler - NAKED SUNDAY PTY LTD (746918845)
Establishment
NameAddressID/FEIBusiness Operations
WILD CHILD W A PTY LTD744660692manufacture(81104-111) , relabel(81104-111)

Revised: 9/2021
Document Id: cbe4d1b2-1598-5912-e053-2a95a90a6769
Set id: cbe4d1b2-1597-5912-e053-2a95a90a6769
Version: 1
Effective Time: 20210913
 
NAKED SUNDAY PTY LTD