SURFERS SKIN SUNSCREEN LIP BALM - avobenzone, octinoxate, octocrylene stick 
Skin Alive, 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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Surfers Skin Sunscreen Lip Balm

Active Ingredients

Avobenzone 2.5%
Octinoxate 7.5%
Octocrylene 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

Provides high protection against sunburn

Regains SPF after 80 minutes of sweating.

Warnings

For external use only

UV exposure from the sun increases the risk of skin cancer, premature skin aging and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.


When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if irritation occurs or rash develops ad lasts.

Keep out of reach of children.

Directions
Apply generously 15 mins before sun exposure and as needed
Children under 6 months of age; ask a doctor
Reapply as needed or after towel drying, swimming or sweating.

Inactive Ingredients

Aloe vera, Beeswax, Capryllic/Capric Triglyceride, Castor Oil, Jojoba Oil, Lanolin, Tocopheryl Acetate, Vanilla lip

Surfers Skin SPF 30+ Sunscreen Lip Balm moisturizes lips with Vitamin E and Aloe Vera


To report a serious adverse event, contact 1-800-332-1088

Expires:

Lot Number:

www.surfersskin.co

DIST. BY Quiver Dist, Bend Oregon, USA 97701

AS/ANZ STANDARD 2604-1998

Tested on Sursfers - Not Animals

Net Wt. .3oz (8.5g)

SPF 30+

very water / sweat resistant

broad spectrum

UVA/UVB protection



Proven in extreme New Zealand conditions

Surfers Skin sunscreen lip balm


Net Wt. .30 oz (8.5g)

contains no nanoparticles - aminobenzoic acid (PABA)-free

Surfers Skin Lip Balm

Surfer Skin Sunscreen

SURFERS SKIN SUNSCREEN LIP BALM 
avobenzone, octinoxate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75916-0660
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
LANOLIN (UNII: 7EV65EAW6H)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
VANILLA (UNII: Q74T35078H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75916-0660-81 in 1 BOX
18.5 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/17/2011
Labeler - Skin Alive, Ltd. (593384746)

Revised: 1/2011
Document Id: 6d887782-a098-40f7-b9b0-419be858a36a
Set id: d49062c4-90b1-4db5-b616-1971fa628346
Version: 1
Effective Time: 20110117
 
Skin Alive, Ltd.