BIG CLOUD SKY MASTER LIP BALM SPF 15- avobenzone, homosalate, octisalate, and octocrylene lipstick

Big Cloud Sky Master Lip Balm SPF 15 by

Drug Labeling and Warnings

Big Cloud Sky Master Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Dollar Shave Club. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 7%, Octisalate 5%, Octocrylene 2.75%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• children under 6 months: 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 including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Dehydroacetic Acid, Euphorbia Cerifera (Candelilla) Wax, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Vegetable Oil, Jojoba Esters, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL - 4.25 g Cylinder Carton

BIG CLOUD

SKY MASTER
LIP BALM
with sunscreen

– MINT LEAF –

"SUN SCREEN. NO SHEEN."

1 STICK

BROAD SPECTRUM
SPF 15

FULL SHIELD
SPF
15
UVA
UVB

WATER RESISTANT
(40 MINUTES)

NET WT. 4.25 g | 0.15 oz

INGREDIENTS AND APPEARANCE

BIG CLOUD SKY MASTER LIP BALM SPF 15 
avobenzone, homosalate, octisalate, and octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69522-2315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
OLIVE OIL (UNII: 6UYK2W1W1E)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69522-2315-1	1 in 1 CARTON	04/06/2016
1		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2	NDC: 69522-2315-2	2 in 1 CARTON	04/06/2016
2		4.25 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2016

Labeler - Dollar Shave Club (004164494)