FDA.reportPublic FDA data

Active SPF 30

Manufacturer
CP Skin Health Group, Inc.
Effective date
2022-06-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:57:53

Label at a glance#

ProductActive SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, ZINC OXIDE
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 and early skin aging caused by the sun

Dosage and administration

Hold container 4 to 6 inches from the skin to apply Spray liberally and spread evenly by hand 15 minutes before sun exposure Do not spray directly into face. Spray on hands then apply to face. Do not apply in windy conditions Use in a well-ventilated area Reapply -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours Children under 6 months: ask a doctor Sun Protection Me...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octisalate (4.9%)

Octocrylene (9.5%)

Zinc Oxide (10.6%)

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 and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if skin rash occurs

When using this product keep out of eyes. If the product is accidentally sprayed into eyes rinse with water to remove.

Contents under pressure

Do not puncture or incinerate

Do not expose to heat or store at temperatures above 120 F

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

Hold container 4 to 6 inches from the skin to apply

Spray liberally and spread evenly by hand 15 minutes before sun exposure

Do not spray directly into face. Spray on hands then apply to face.

Do not apply in windy conditions

Use in a well-ventilated area

Reapply

-after 80 minutes of swimming or sweating

-immediately after towel drying

-at least every 2 hours

Children under 6 months: ask a doctor

Sun Protection 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 borad spectrum SPF value of 15 or higher and other skin protecting measures including:

-limit time in the sun, epseically from 10 a.m. to 2 p.m.

-wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bentonite

Bisabolol

Brassica Campestris/Aleurites Fordi Oil Copolymer

Butyloctyl Salicylate

Caprylhydroxamic Acid

Caprylic/Capric Triglyceride

Caprylyl Glycol

Cellulose Gum

Cetearyl Alcohol

Citric Acid

Coco-Glucoside

Cucumis Melo (Melon) Fruit Extract

Cucumis Melo Cantalupensis Fruit Extract

Cucumis Sativus (Cucumber) Fruit Extract

Dimethicone

Ectoin

Ethyl Ferulate

Ethyl Macadamiate

Glycerin

Jojoba Esters

Mentha Piperita (Peppermint) Extract

Mentha Viridis (Spearmint) Extract

Methyl Dihydroabietate

Microcrystalline Cellulose

Passiflora Incarnata Fruit Extract

Polyhydroxystearic Acid

Potassium Cetyl Phosphate

Propanediol

Pyrus Malus (Apple) Fruit Extract

Rose Extract

Rubus Idaeus (Raspberry) Fruit Extract

Santalum Album (Sandalwood) Wood Extract

Simmondsia Chinensis (Jojoba) Seed Oil

Tocopherol

Water

Questions or Comments?

OTC - QUESTIONS SECTION

877.722.7546

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68726-26668726-266-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ECTOINE7GXZ3858RYIACT
JOJOBA OIL724GKU717MIACT
ETHYL FERULATE5B8915UELWIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
COCO GLUCOSIDEICS790225BIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TOCOPHEROLR0ZB2556P8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYL MACADAMIATEANA2NCS6V1IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
RASPBERRY4N14V5R27WIACT
APPLEB423VGH5S9IACT
MENTHA X PIPERITA WHOLE79M2M2UDA9IACT
MENTHA SPICATA WHOLEO2H83I4PUNIACT
CUCUMBERYY7C30VXJTIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MUSKMELONZV095H5633IACT
PASSIFLORA INCARNATA FRUITSF206I8G4PIACT
DIMETHICONE92RU3N3Y1OIACT
ROSA X ALBA FLOWER OILFF1Y064QVOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PROPANEDIOL5965N8W85TIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SANDALWOOD3641YW25N2IACT
CANTALOUPE8QF5D5H6UHIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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
e2988284-5d7b-6637-e053-2a95a90acf1eb7c510e6-9c40-e6ea-e053-2a95a90a17d22022-06-29WarningsExact identifier
spl id: e2988284-5d7b-6637-e053-2a95a90acf1e
spl set id: b7c510e6-9c40-e6ea-e053-2a95a90a17d2

Reported adverse events (FAERS/openFDA)#

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