CONSCIOUS SUNSCREEN, PROTECT-RESPECT, FACE SPF-40- zinc oxide, titanium dioxide stick

CONSIOUS SUNSCREEN, PROTECT-RESPECT, FACE by

Drug Labeling and Warnings

CONSIOUS SUNSCREEN, PROTECT-RESPECT, FACE by is a Otc medication manufactured, distributed, or labeled by SOLID SUN LOGISTICS, Health Specialty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

MICRONIZED ZINC OXIDE  17%

TITANIUM DIOXIDE  3%

PURPOSE

SUNSCREEN

USES

HELPS PREVENT SUNBURN. IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER, EARLY SKIN AGING BY THE SUN.

WARNING

• FOR EXTERNAL USE ONLY.
• DO NOT USE ON DAMAGED OR BROKEN SKIN.
• STOP USE AND CONTACT A DOCTOR IS RASH OCCURS.
• WHEN USING THIS PRODUCT KEEP  OUT OF EYES. RINSE WITH WATER TO REMOVE.

KEEP OUT OF REACH OF CHILDREN

• 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:

• AFTER 80 MINUTES OF SWIMMING OR SWEATING
• AT LEAST EVERY 2 HOURS OR IMMEDIATELY AFTER TOWEL DRYING.

SUN PROTECTION MEASURES:

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THE RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:

• LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM - 2 PM
• WEAR LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES
• CHILDREN UNDER 6 MONTHS, ASK A DOCTOR

INACTIVE INGREDIENTS

CASTOR SEED OIL, BEESWAX, C12-15 ALKYL BENZOATE, CAPRYLIC CAPRIC TRIGLYCERIDES, DICAPRYLYL ETHER, CARNAUBA WAX, SHEA BUTTER, KAOLIN, VITAMIN E ACETATE, ALOE LEAF JUICE, GREEN TEA EXTRACT, SEA KELP EXTRACT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONSCIOUS SUNSCREEN, PROTECT-RESPECT, FACE  SPF-40
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71524-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	17 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
KAOLIN (UNII: 24H4NWX5CO)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71524-102-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/25/2017

Labeler - SOLID SKIN LLC (080721409)

Establishment
Name	Address	ID/FEI	Business Operations
HealthSpecialty		794053863	manufacture(71524-102)