FDA.reportPublic FDA data

CONSCIOUS SUNSCREEN, PROTECT-RESPECT

Manufacturer
SOLID SKIN LLC | HealthSpecialty
Effective date
2020-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:46:47

Label at a glance#

ProductCONSCIOUS SUNSCREEN, PROTECT-RESPECT SPF-50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

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 S...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MICRONIZED ZINC OXIDE  7%

TITANIUM DIOXIDE  5%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 50 Body LotionSPF 50 Body Lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71524-101-112024-04-01C16284748780-1d6a99b39-6c00-a426-e053-dadaa90af4c2721934fd-5597-4537-9a30-c450731f1ce2
71524-101-112022-01-28C16284748780-1d6a99b39-6c00-a426-e053-dadaa90af4c2721934fd-5597-4537-9a30-c450731f1ce2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71524-10171524-101-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
DICAPRYLYL ETHER77JZM5516ZIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISOSTEARIC ACIDX33R8U0062IACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOIC ACID8SKN0B0MIMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
SODIUM CHLORIDE451W47IQ8XIACT
LACTOBACILLIC ACIDSVS08S87RLIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
SPIRULINA MAXIMA9K7IG15M0QIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALLANTOIN344S277G0ZIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
150f943e-62a7-8ccf-e063-6294a90aabca721934fd-5597-4537-9a30-c450731f1ce22024-04-01WarningsExact identifier
spl set id: 721934fd-5597-4537-9a30-c450731f1ce2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.