NDC 76138-204

SPF 30 Sunscreen

Octinoxate, Oxybenzone, Octisalate, Titanium Dioxide

SPF 30 Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Innovation Specialties. The primary component is Octinoxate; Oxybenzone; Octisalate; Titanium Dioxide.

Product ID76138-204_43aa6fc2-8ea9-4795-8885-b3da02eee2bb
NDC76138-204
Product TypeHuman Otc Drug
Proprietary NameSPF 30 Sunscreen
Generic NameOctinoxate, Oxybenzone, Octisalate, Titanium Dioxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2013-06-05
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameINNOVATION SPECIALTIES
Substance NameOCTINOXATE; OXYBENZONE; OCTISALATE; TITANIUM DIOXIDE
Active Ingredient Strength8 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76138-204-03

30 mL in 1 BOTTLE (76138-204-03)
Marketing Start Date2013-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76138-204-03 [76138020403]

SPF 30 Sunscreen LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-05
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.5 mg/mL

OpenFDA Data

SPL SET ID:cba4d2c5-d247-45e1-8b1e-9d26fb3745f6
Manufacturer
UNII

NDC Crossover Matching brand name "SPF 30 Sunscreen" or generic name "Octinoxate, Oxybenzone, Octisalate, Titanium Dioxide"

NDCBrand NameGeneric Name
31190-320SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
31190-330SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
53942-002SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
53942-005SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
57817-300SPF 30 SunscreenOCTINOXATE OXYBENZONE Octisalate
70412-239SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-011SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-012SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-013SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-014SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71585-110SPF 30 SunscreenZINC OXIDE
72839-029SPF 30 SunscreenAvobenzone 3%, Homosalate 8%, Octisalate 5%, Octocrylene 3%
72839-523SPF 30 SunscreenAvobenzone 3%, Octisalate 5%, Octocrylene 8%
76138-203SPF 30 SunscreenOCTINOXATE, OXYBENZONE, OCTISALATE
76138-204SPF 30 SunscreenOctinoxate, Oxybenzone, Octisalate, Titanium Dioxide
79021-010SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
76150-244Big Cloud DefendSPF 30 Sunscreen
37808-924H.E.B ULTRASPF 30 Sunscreen
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.