DAILY DEFENDER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (80 MINUTES)- zinc oxide cream

Daily Defender Mineral Sunscreen Broad Spectrum SPF 50 Water Resistant (80 minutes) by

Drug Labeling and Warnings

Daily Defender Mineral Sunscreen Broad Spectrum SPF 50 Water Resistant (80 minutes) by is a Otc medication manufactured, distributed, or labeled by Thrive Causemetics, Cosmetic Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 19.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk 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

For sunscreen use:

• Apply liberally 15 minutes before sun exposure.
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
• Children under 6 months of age: 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 am. - 2 pm.
  • Wear long-sleeved shirts, pants, and sunglasses.

Other information

• Protect this product in this container from excessive heat and direct sun.

Questions?

Call (888) 804-4318 or visit www.thrivecausemetics.com

Inactive ingredients

AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIISOOCTYL SUCCINATE, PROPANEDIOL, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, NIACINAMIDE, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, POLYMETHYLSILSESQUIOXANE, CETEARYL OLIVATE, MAGNESIUM ALUMINUM SILICATE, POLYHYDROXYSTEARIC ACID, TERMINALIA FERDINANDIANA FRUIT EXTRACT, VACCINIUM VITIS-IDAEA FRUIT EXTRACT, PONGAMIA PINNATA SEED EXTRACT, MALEATED SOYBEAN OIL GLYCERYL/OCTYLDODECANOL ESTERS, ECTOIN, ALOE BARBADENSIS LEAF JUICE, SODIUM HYALURONATE, ASCORBYL TETRAISOPALMITATE, MENTHYL LACTATE, JOJOBA ESTERS, TRIETHOXYCAPRYLYLSILANE, ARACHIDYL ALCOHOL, SILICA, LAUROYL LYSINE, POTASSIUM CETYL PHOSPHATE, POLYGLYCERYL-4 LAURATE/SUCCINATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISONONYL ISONONANOATE, OCTYLDODECANOL, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, POLYGLUTAMIC ACID, SORBITAN OLEATE, TRIHYDROXYSTEARIN, ARACHIDYL GLUCOSIDE, SORBITAN OLIVATE, BEHENYL ALCOHOL, XANTHAN GUM, GLUCONOLACTONE, CALCIUM GLUCONATE, TETRASODIUM GLUTAMATE DIACETATE, CITRIC ACID, SODIUM BENZOATE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499)].

SPL UNCLASSIFIED SECTION

Dist. by Thrive Causemetics, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

bigger
than
beauty®
SKINCARE

DERMATOLOGIST
RECOMMENDED

DAILY DEFENDER™

MINERAL
SUNSCREEN

Broad Spectrum SPF 50

Barrier Power Boost™

Water Resistant (80 minutes)

UNTINTED

1.7 fl oz / 50 mL

INGREDIENTS AND APPEARANCE

DAILY DEFENDER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 WATER RESISTANT (80 MINUTES) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77365-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIISOBUTYL SUCCINATE (UNII: 1241X4J800)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
LINGONBERRY (UNII: 0UNK9RZQ7X)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
SOYBEAN OIL GLYCERETH-8 ESTERS (UNII: 8Y338J838M)
ECTOINE (UNII: 7GXZ3858RY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LAUROYL LYSINE (UNII: 113171Q70B)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
OCTYLDODECANOL (UNII: 461N1O614Y)
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)
POLYGLUTAMIC ACID (8000 MW) (UNII: D4JEG46UXV)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77365-009-01	1 in 1 BOX	08/12/2024
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 drug	M020	08/12/2024

Labeler - Thrive Causemetics (039299574)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Solutions, LLC		807907928	MANUFACTURE(77365-009)