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

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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Big Cloud Sky Master Lip Balm SPF 15

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

SPF
15
UVA
UVB

WATER RESISTANT
(40 MINUTES)

NET WT. 4.25 g | 0.15 oz

Principal Display Panel - 4.25 g Cylinder Carton
BIG CLOUD SKY MASTER LIP BALM SPF 15 
avobenzone, homosalate, octisalate, and octocrylene lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69522-2315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69522-2315-11 in 1 CARTON04/06/201611/18/2022
14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:69522-2315-22 in 1 CARTON04/06/201611/18/2022
24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/201611/18/2022
Labeler - Dollar Shave Club (004164494)

Revised: 11/2022
Document Id: 06dd892a-1211-4880-b24d-16f78875984a
Set id: 94adecc0-faf4-45b2-9d6c-372f8e0b75e4
Version: 4
Effective Time: 20221115
 
Dollar Shave Club