Active Ingredients

titanium dioxide 4.5%

zinc oxide 3.4%

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

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

If product is 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
Children under 6 months of age: Ask a doctor.
Sunprotection 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 10am-2pm
wear long-sleeved shirts, pants, hats and sunglasses.

Inactive ingredients

ALUMINA

ARGANIA SPINOSA KERNEL OIL

BISABOLOL

BUTYLENE/ETHYLENE/STYRENE COPOLYMER

BUTYLOCTYL SALICYLATE

CAPRYLIC/CAPRIC TRIGLYCERIDE

CAPRYLYL GLYCOL

CITRUS RETICULATA (TANGERINE) PEEL OIL

ETHYLENE/PROPYLENE/STYRENE COPOLYMER

FLAVOR

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

HYDROGENATED POLYISOBUTENE

IRON OXIDES

PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE

POLYHYDROXYSTEARIC ACID

RICINUS COMMUNIS (CASTOR) SEED OIL

STEARIC ACID

TOCOPHERYL ACETATE

Other information

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

label

BRUSH ON BLOCK SUN SHINE SPF 30 PROTECTIVE LIP OIL CORAL
titanium dioxide/zinc oxide oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58274-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.5 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ARGAN OIL (UNII: 4V59G5UW9X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
MANDARIN OIL (UNII: NJO720F72R)
LEVOMENOL (UNII: 24WE03BX2T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Product Characteristics
Color		Score
Shape		Size
Flavor	TANGERINE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58274-017-01	6.8 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	03/05/2024

Labeler - SPF Ventures LLC (055483891)

Name	Address	ID/FEI	Business Operations
Establishment
Dermaceutical Laboratories Limited Liability		078457159	manufacture(58274-017)

Name	Address	ID/FEI	Business Operations
Establishment
Dermaceutical Laboratories Limited Liability		080375664	manufacture(58274-017)

Brush On Block Sun Shine SPF 30 Protective Lip Oil Coral