PROTECTIVE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide paste

Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs LLC, June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Titanium Dioxide........... 4.31%

Zinc Oxide....................19.27%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

• In case of contact with eyes, rinse with water
• If rash occurs, stop use and consult a doctor

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Use daily after cleanser or serum for protective moisture and younger-looking skin. Apply to face and neck liberally 15 minutes before sun exposure. Reapply at least every two hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 sleeve shirts, pants, hats and sunglasses
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients

Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco Caprylate/Caprate, Behenyl Behenate, Sorbitol/Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

OTHER SAFETY INFORMATION

Other information

■ Protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments?

Call toll free 1-866-JUNEJACOBS ■ www.JUNEJACOBS.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTIVE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 
titanium dioxide, zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.693 g  in 50.28 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.169 g  in 50.28 g

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ARGAN OIL (UNII: 4V59G5UW9X)
MALIC ACID (UNII: 817L1N4CKP)
GLYCERIN (UNII: PDC6A3C0OX)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
LAUROYL LYSINE (UNII: 113171Q70B)
JUNIPER BERRY OIL (UNII: SZH16H44UY)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
LITSEA OIL (UNII: 2XIW34BN6O)
GINGER OIL (UNII: SAS9Z1SVUK)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
CASTOR OIL (UNII: D5340Y2I9G)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALUMINUM OXIDE (UNII: LMI26O6933)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
LAVANDIN OIL (UNII: 9RES347CKG)
VETIVER OIL (UNII: 9M9P32M01L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
GALBANUM (UNII: C690YC9N2Z)
CITRAL (UNII: T7EU0O9VPP)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
CANDELILLA WAX (UNII: WL0328HX19)
ORANGE OIL (UNII: AKN3KSD11B)
VITIS VINIFERA SEED (UNII: C34U15ICXA)

Product Characteristics
Color	brown (Nude/Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-104-01	50.28 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2021
2	NDC: 65278-104-02	50.28 g in 1 CARTON; Type 0: Not a Combination Product	09/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/08/2021

Labeler - June Jacobs Labs LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-104)