GNARLY HEAD SPF 30- octocrylene, octisalate, avobenzone lipstick

Gnarly Head SPF 30 by

Drug Labeling and Warnings

Gnarly Head SPF 30 by is a Otc medication manufactured, distributed, or labeled by Tropical Seas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• helps prevent chapped or cracked skin
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging 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 a 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 liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - Label

Gnarly Head ®

SANGRIA

Broad Spectrum

SPF 30 LIP BALM

Net Weight .15 oz. (4.44 gm)

INGREDIENTS AND APPEARANCE

GNARLY HEAD SPF 30 
octocrylene, octisalate, avobenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-581
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LAURYL LAURATE (UNII: GPW77G0937)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
YELLOW WAX (UNII: 2ZA36H0S2V)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENETHYL BENZOATE (UNII: 0C143929GK)
COCONUT (UNII: 3RT3536DHY)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-581-01	4.44 g in 1 TUBE; Type 0: Not a Combination Product	12/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/14/2018

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-581)