Label: SHEER MATTE SPF 30- zinc oxide 10.5% lotion
- NDC Code(s): 79753-044-01
- Packager: COOLA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 20, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• shake well
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes 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 this risk, regularly use a
sunscreen with a broad spectrum SPF of 15 or
higher and after 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 INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC),
Caprylic/Capric Triglyceride (ORGANIC), Butyloctyl
Salicylate, Polyglyceryl-4 Laurate/Succinate,
Glycerin (ORGANIC), Methyl Methacrylate
Crosspolymer, Poly C-10-30 Alkyl Acrylate, Sorbitan
Oleate, Trimethoxybenzylidene Pentanedione,
Arachidyl Alcohol, Hydroxyethyl Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer, Carthamus
Tinctorius (Safflower) Oleosomes, Mauritia Flexuosa
Fruit Oil (ORGANIC), Rubus Idaeus (Raspberry) Seed
Oil (ORGANIC), Limnanthes Alba (Meadowfoam)
Seed Oil, Oenothera Biennis (Evening Primrose) Oil
(ORGANIC), Rosa Canina Seed Oil (ORGANIC),
Helianthus Annuus (Sunflower) Seed Oil, Ricinus
Communis (Castor) Seed Oil, Opuntia Vulgaris
Extract, Behenyl Alcohol, Polyhydroxystearic Acid,
Isostearic Acid, Benzyl Alcohol, Arachidyl Glucoside,
Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Citric
Acid, Hydrogenated Polyisobutene, Iron Oxides, Cl
77891, Sorbitan Isostearate, Cl 77492, Cl 77491,
Disteardimonium Hectorite, Cl 77499, Propylene
Carbonate, Gluconolactone, Sodium Benzoate - OTHER SAFETY INFORMATION
- QUESTIONS
- Package for COOLA Mineral Face Sunscreen Sheer Matte SPF 30
-
INGREDIENTS AND APPEARANCE
SHEER MATTE SPF 30
zinc oxide 10.5% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79753-044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS) GLYCERIN (UNII: PDC6A3C0OX) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) RASPBERRY SEED OIL (UNII: 9S8867952A) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) ROSA CANINA SEED OIL (UNII: MHT97MG5P8) SUNFLOWER OIL (UNII: 3W1JG795YI) CASTOR OIL (UNII: D5340Y2I9G) OPUNTIA FICUS-INDICA SEED OIL (UNII: 1XGW49AK2J) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) XANTHAN GUM (UNII: TTV12P4NEE) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERROUS OXIDE (UNII: G7036X8B5H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GLUCONOLACTONE (UNII: WQ29KQ9POT) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79753-044-01 1 in 1 PACKAGE 02/01/2022 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 02/01/2022 Labeler - COOLA (956990290) Registrant - Bentley Laboratories, LLC (068351753) Establishment Name Address ID/FEI Business Operations Bentley Laboratories, LLC 068351753 manufacture(79753-044)
