BIG CLOUD DEFEND DAILY FACE MOISTURIZER BROAD SPECTRUM SPF30- avobenzone, homosalate and octocrylene lotion lotion

Big Cloud Defend Daily Face Moisturizer Broad Spectrum SPF30 by

Drug Labeling and Warnings

Big Cloud Defend Daily Face Moisturizer Broad Spectrum SPF30 by is a Otc medication manufactured, distributed, or labeled by Dollar Shave Club, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

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 at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.

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. Children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Diisopropyl Adipate, Ceteareth-6 Olivate, Glycerin, Butyloctyl Salicylate, Cetearyl Olivate, Polymethylsilsesquioxane, Butyrospermum Parkii (SHea) Butter, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Anogeissus Leiocarpa Bark Extract, Sorbitan Olivate, Caprylyl Glycol, Silica, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Caprylhydroxamic Acid, Sodium Phytate, Xanthan Gum, Sodium Hydroxide, Citric Acid, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Alpha-Isomethyl Ionone, Coumarin, Hydroxycitronellal, Linalool, Fragrance.

Principle Display Panel

Image content

INGREDIENTS AND APPEARANCE

BIG CLOUD DEFEND DAILY FACE MOISTURIZER BROAD SPECTRUM SPF30 
avobenzone, homosalate and octocrylene lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69522-2618
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 mg  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
MINT (UNII: FV98Z8GITP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
COUMARIN (UNII: A4VZ22K1WT)
LINALOOL, (+)- (UNII: F4VNO44C09)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
FIG (UNII: TGD87RII2U)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
CETEARETH-6 OLIVATE (UNII: 8834VWF9MO)
CETEARYL OLIVATE (UNII: 58B69Q84JO)

Product Characteristics
Color	white (Off White to White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69522-2618-1	1 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020
2	NDC: 69522-2618-2	1 mg in 1 TUBE; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2020

Labeler - Dollar Shave Club, Inc. (004164494)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp Incorporated		064187883	manufacture(69522-2618)