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

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Solid Skin (as PLD) - CONSCIOUS SUNSCREEN, PROTECT-RESPECT (71524-101) - DELIST

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. 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

SPF 50 Body Lotion

CONSCIOUS SUNSCREEN, PROTECT-RESPECT  SPF-50
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71524-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71524-101-11150 mL in 1 BOTTLE; Type 0: Not a Combination Product07/25/201712/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02007/25/201712/31/2023
Labeler - SOLID SKIN LLC (080721409)

Revised: 4/2024
 
SOLID SKIN LLC