CONSCIOUS SUNSCREEN, PROTECT-RESPECT SPF-50- zinc oxide, titanium dioxide cream

CONSCIOUS SUNSCREEN, PROTECT-RESPECT by

Drug Labeling and Warnings

CONSCIOUS SUNSCREEN, PROTECT-RESPECT 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  7%

TITANIUM DIOXIDE  5%

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. WHEN USING THIS PRODUCT KEEP  OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND CONTACT A DOCTOR IS RASH OCCURS.

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

WATER, CAPRYLIC/CAPRIC TRIGLYCERIDES, C12-15 ALKYL BENZOATE, GLYCERIN, PROPANEDIOL, DICAPRYLYL ETHER, POLYHYDROXYSTEARIC ACID, ISOSTEARIC ACID, OCTYLDODECYL STEARYL CITRATE CROSSPOLYMER, PHENOXYETHANOL, BENZOIC ACID, ETHYLHEXYLGLYCERIN, GLYCERETH-2 COCOATE, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM CHLORIDE, SEA KELP (LACTOBACILLUS/KELP FERMENT FILTRATE), MACROCYSTIS PYRIFERA (SEA KELP) EXTRACT (AND) SPIRULINA MAXIMA (BLUE ALGAE) EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, SODIUM HYALURONATE ACID POWDER, ALLANTOIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CONSCIOUS SUNSCREEN, PROTECT-RESPECT  SPF-50
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71524-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LACTOBACILLIC ACID (UNII: SVS08S87RL)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71524-101-11	150 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(71524-101)