SOLARA SUNCARE - GO! DAILY DEFENSE PROBIOTIC MINERAL FACE MOISTURIZER (73054-106) - DELIST

DAILY DEFENSE MINERAL FACE MOISTURIZER by

Drug Labeling and Warnings

DAILY DEFENSE MINERAL FACE MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by SOLARA SUNCARE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY DEFENSE MINERAL FACE MOISTURIZER SPF-30- zinc oxide lotion 
SOLARA SUNCARE, INC.

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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SOLARA SUNCARE - GO! DAILY DEFENSE PROBIOTIC MINERAL FACE MOISTURIZER (73054-106) - DELIST

ACTIVE INGREDIENTS

Zinc Oxide 19%

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

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

• shake or knead before each use
• apply generously and evenly 15 minutes before sun exposure
• reapply:
• after 40 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 the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Coco-Glucoside, Lactobacillus Ferment, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Sprout Extract, Hydrolyzed Jojoba Esters, Butyrospermum Parkii Nut Extract, Caesalpinia Spinosa Fruit Pod Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Caprylyl/Capryl Glucoside, Coco-Caprylate/Caprate, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Dipotassium Glycyrrhizinate, Sodium Phytate, Propylene Glycol, Xanthan Gum, Sclerotium Gum, Phenoxyethanol, Sodium Benzoate, Tocopherol

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

QUESTIONS OR COMMENTS

• 1-855-859-1600 (9am – 5pm ET)

DAILY DEFENSE MINERAL FACE MOISTURIZER  SPF-30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73054-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT ALKANES (UNII: 1E5KJY107T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO GLUCOSIDE (UNII: ICS790225B)
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
SQUALANE (UNII: GW89575KF9)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCO-CAPRYLATE (UNII: 4828G836N6)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PHYTATE SODIUM (UNII: 88496G1ERL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73054-106-11	1 in 1 BOX	10/17/2021	10/17/2021
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	10/17/2021	10/17/2021

Labeler - SOLARA SUNCARE, INC. (040998319)

Revised: 5/2023

Document Id: fd03fde3-75e4-8d30-e053-6394a90a9fde

34390-5

Set id: 67fffe86-9ac5-4276-ae8c-fe287e3e7d15

Version: 5

Effective Time: 20230531